Infection, Human Immunodeficiency Virus
Conditions
Keywords
antiretroviral therapy naive subjects, fosamprenavir, HIV-1, protease inhibitor, pro-drug, antiretroviral therapy, LEXIVA, AGENERASE, GW433908, amprenavir
Brief summary
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.
Detailed description
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Interventions
DRUGfosamprenavir (GW433908)
DRUGritonavir
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant/non-lactating females \>/=13 years of age (or \>/= 18 years of age according to local requirements). * Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.
Exclusion criteria
* Permanent discontinuation of GW433908 in a previous study due to intolerance. * An active CDC Class C Event. * Any condition which, in the opinion of the investigator, would preclude a subject from participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE): Interim Analysis | Baseline (Day 1) up to 31 January 2006 (up to Week 264) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section. |
| Number of Participants With Any Adverse Event (AE): Final Analysis | Post January 2006; for up to 241 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section. |
| Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1). |
| Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Weeks 120, 180, 204, 216, and 432 | Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). |
| Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216 | blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1). |
| Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Baseline (Day 1) and Weeks 48, 96, 132, and 168 | Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1). |
| Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 | Weeks 120, 180, 204, 216, and 432 | Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. |
| Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216 | Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1). |
| Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Baseline (Day 1) and Weeks 48, 96, 132, and 168 | Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1). |
| Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | Weeks 120, 180, 204, 216, and 432 | Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline and Weeks 48, 120, 180, and 216 | Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline. |
| Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Baseline (Day 1) up to 31 January 2006 (up to Week 264) | The number of participants with the indicated HIV-associated conditions were assessed. |
| Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline and Weeks 12, 24, 48, 60, 96, and 132 | Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. |
| Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) | Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 | Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs. |
| Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Baseline and Weeks 48, 120, 168, 180, 204, and 216 | Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV. |
| Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Baseline and Weeks 24, 48, 96, 132, and 168 | Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV. |
| Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Blood samples of participants were collected for the assessment of plasma HIV-1 RNA. |
| Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Blood samples of participants were collected for the assessment of plasma HIV-1 RNA. |
| Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 | Weeks 180, 240, 300, 360, 420, and 432 | Blood samples of participants were collected for the assessment of plasma HIV-1 RNA. |
| Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | Baseline (Day 1) up to 31 January 2006 (up to Week 264) | The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study. |
| Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Baseline (Day 1) up to 31 January 2006 (up to Week 264) | The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences. |
Countries
Brazil, Chile, France, Italy, Portugal, Spain, United Kingdom, United States
Participant flow
Recruitment details
APV30005 enabled Human Immunodeficiency Virus (HIV)-infected participants who had received a Fosamprenavir (FPV)-containing or other regimen in a number of studies, including APV30001, APV30002, and APV30003, to receive FPV until 31 January 2006 (Interim Analysis) or until commercial supplies of FPV were available locally, whichever was later.
Pre-assignment details
Participants are divided into arms depending on the regimen they received in Studies APV30001, APV30002, and APV30003 or whether they were PI-naïve or PI-experienced at the time they enrolled into other studies. For the final analysis, 111 participants are included who continued in APV30005 after 31 January 2006 until study completion.
Participants by arm
| Arm | Count |
|---|---|
| FPV Population (APV30001) FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554) | 119 |
| NFV Population (APV30001) FPV +/- RTV + background regimen in participants who had received NFV in APV30001 | 18 |
| FPV Population (APV30002) FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061) | 221 |
| NFV Population (APV30002) FPV +/- RTV + background regimen in participants who had received NFV in APV30002 | 54 |
| FPV/RTV QD Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number) | 73 |
| FPV/RTV BID Population (APV30003) FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003 | 78 |
| PI-Naïve Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study | 104 |
| PI-Experienced Population (Other Studies) FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study | 86 |
| Total | 753 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Final Analysis | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Final Analysis | Insufficient Viral Load Response | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
| Final Analysis | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 |
| Final Analysis | Participant Moved to Another Country | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Final Analysis | Poor Adherence | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Final Analysis | Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
| Final Analysis | Tuberculosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Final Analysis | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Interim Analysis | Adverse Event | 0 | 0 | 13 | 4 | 6 | 3 | 4 | 5 | 0 |
| Interim Analysis | Clinical Progression | 1 | 0 | 1 | 1 | 0 | 2 | 1 | 2 | 0 |
| Interim Analysis | Death | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Inclusion in Other Protocol | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Insufficient CD4 Response | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Interim Analysis | Insufficient Viral Load Response | 5 | 1 | 12 | 2 | 7 | 9 | 2 | 24 | 0 |
| Interim Analysis | Lack of Personnel at Site | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Lost to Follow-up | 13 | 3 | 26 | 8 | 14 | 4 | 11 | 4 | 0 |
| Interim Analysis | Missed Schedule Date | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Non-adherence | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Interim Analysis | Ongoing | 32 | 12 | 16 | 22 | 0 | 0 | 30 | 1 | 0 |
| Interim Analysis | Participant Had Problems with Alcohol | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Participant Moved | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Interim Analysis | Participant Needed Interferon | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Interim Analysis | Participant Non-compliant | 0 | 1 | 2 | 1 | 1 | 3 | 6 | 2 | 0 |
| Interim Analysis | Participant Stopped | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Interim Analysis | Participant Stopped HIV Medications | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Interim Analysis | Participant Wanted to Become Pregnant | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
| Interim Analysis | Participant Was Incarcerated | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Physician and Participant Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Interim Analysis | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Pregnancy | 4 | 1 | 4 | 2 | 0 | 1 | 1 | 1 | 0 |
| Interim Analysis | Principle Investigator Discretion | 2 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Principle Investigator Terminated Study | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Protocol Violation | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 1 | 0 |
| Interim Analysis | Resistance to FPV | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Interim Analysis | Site Closing | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 |
| Interim Analysis | Study Ended | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Interim Analysis | Switched to Commercially Available Drug | 2 | 0 | 4 | 1 | 0 | 5 | 3 | 4 | 0 |
| Interim Analysis | To Simplify Treatment | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 |
| Interim Analysis | Withdrawal by Subject | 8 | 0 | 12 | 0 | 5 | 5 | 9 | 3 | 0 |
Baseline characteristics
| Characteristic | PI-Naïve Population (Other Studies) | FPV/RTV BID Population (APV30003) | FPV/RTV QD Population (APV30003) | NFV Population (APV30002) | FPV Population (APV30002) | NFV Population (APV30001) | FPV Population (APV30001) | Total | PI-Experienced Population (Other Studies) |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 39.3 years | 42.3 years | 41.9 years | 36.2 years | 37.7 years | 35.8 years | 36.3 years | 38.7 years | 40.2 years |
| Number of Participants with the Indicated CDC Classification of HIV Infection Acquired Immune Deficiency Syndrome (AIDS) | 5 participants | 24 participants | 26 participants | 18 participants | 49 participants | 1 participants | 21 participants | 183 participants | 39 participants |
| Number of Participants with the Indicated CDC Classification of HIV Infection Asymptomatic or lymphadenopathy | 76 participants | 30 participants | 26 participants | 13 participants | 124 participants | 16 participants | 81 participants | 395 participants | 29 participants |
| Number of Participants with the Indicated CDC Classification of HIV Infection Symptomatic, not AIDS | 23 participants | 24 participants | 21 participants | 23 participants | 48 participants | 1 participants | 17 participants | 175 participants | 18 participants |
| Race/Ethnicity, Customized American Hispanic | 23 participants | 7 participants | 3 participants | 2 participants | 16 participants | 11 participants | 49 participants | 113 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 1 participants | 0 participants | 4 participants | 0 participants | 1 participants | 8 participants | 0 participants |
| Race/Ethnicity, Customized Black | 34 participants | 14 participants | 10 participants | 34 participants | 86 participants | 6 participants | 35 participants | 226 participants | 7 participants |
| Race/Ethnicity, Customized Other: Race Not Specified | 2 participants | 0 participants | 0 participants | 4 participants | 6 participants | 0 participants | 0 participants | 12 participants | 0 participants |
| Race/Ethnicity, Customized White | 44 participants | 56 participants | 59 participants | 14 participants | 109 participants | 1 participants | 34 participants | 394 participants | 77 participants |
| Sex: Female, Male Female | 24 Participants | 12 Participants | 9 Participants | 23 Participants | 63 Participants | 9 Participants | 36 Participants | 198 Participants | 22 Participants |
| Sex: Female, Male Male | 80 Participants | 66 Participants | 64 Participants | 31 Participants | 158 Participants | 9 Participants | 83 Participants | 555 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 115 / 119 | 16 / 18 | 209 / 221 | 53 / 54 | 68 / 73 | 73 / 78 | 76 / 104 | 40 / 86 | 82 / 111 |
| serious Total, serious adverse events | 33 / 119 | 1 / 18 | 62 / 221 | 7 / 54 | 20 / 73 | 14 / 78 | 7 / 104 | 13 / 86 | 15 / 111 |
Outcome results
Primary
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 204, n=77, 12, 152, 27 | -10 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 180, n=81, 12, 155, 33 | -10 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 204, n=77, 12, 151, 27 | -7 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 216, n=80, 0, 143, 4 | 5 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 120, n=96, 15, 182, 40 | -9 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 216, n=79, 0, 142, 4 | -9 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 180, n=81, 12, 156, 33 | 4 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 48, n=117, 17, 215, 47 | -7 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 180, n=80, 12, 154, 33 | -10 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase;Week 204, n=78, 12, 153, 27 | 3 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 120, n=96, 15, 182, 40 | -8 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 120, n=95, 15, 184, 40 | 4 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 48, n=118, 17, 217, 47 | 4 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 48, n=117, 17, 216, 47 | -5 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 216, n=79, 0, 142, 4 | -10 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 120, n=95, 15, 184, 40 | 4 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 48, n=117, 17, 215, 47 | -2 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 120, n=96, 15, 182, 40 | 0 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 180, n=80, 12, 154, 33 | 2 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 216, n=79, 0, 142, 4 | NA units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 204, n=77, 12, 151, 27 | 3 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 48, n=117, 17, 216, 47 | 0 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 120, n=96, 15, 182, 40 | -1 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 180, n=81, 12, 155, 33 | 3 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 204, n=77, 12, 152, 27 | 2 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 216, n=79, 0, 142, 4 | NA units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 48, n=118, 17, 217, 47 | 1 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 180, n=81, 12, 156, 33 | -0.5 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase;Week 204, n=78, 12, 153, 27 | 0 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 216, n=80, 0, 143, 4 | NA units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 180, n=80, 12, 154, 33 | -7 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 120, n=95, 15, 184, 40 | -1 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 216, n=79, 0, 142, 4 | -6 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 120, n=96, 15, 182, 40 | -8 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase;Week 204, n=78, 12, 153, 27 | 1 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 180, n=81, 12, 156, 33 | 1 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 204, n=77, 12, 152, 27 | -5 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 48, n=117, 17, 215, 47 | -7 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 48, n=117, 17, 216, 47 | -8 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 48, n=118, 17, 217, 47 | 0 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 204, n=77, 12, 151, 27 | -7 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 180, n=81, 12, 155, 33 | -6 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 120, n=96, 15, 182, 40 | -8 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 216, n=79, 0, 142, 4 | -7 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 216, n=80, 0, 143, 4 | 0 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 180, n=80, 12, 154, 33 | -2 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 180, n=81, 12, 155, 33 | 1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 204, n=77, 12, 152, 27 | -1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase;Week 204, n=78, 12, 153, 27 | 2 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 216, n=79, 0, 142, 4 | -3 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 216, n=79, 0, 142, 4 | 1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 48, n=118, 17, 217, 47 | -2 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 120, n=96, 15, 182, 40 | 1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 120, n=95, 15, 184, 40 | 2 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 216, n=80, 0, 143, 4 | -3 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 204, n=77, 12, 151, 27 | -2 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | Serum lipase; Week 180, n=81, 12, 156, 33 | 1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 48, n=117, 17, 216, 47 | 2 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | AST; Week 48, n=117, 17, 215, 47 | 0 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216 | ALT; Week 120, n=96, 15, 182, 40 | 4 units per liter (U/L) |
Primary
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 96, n=57, 63, 73, 49 | -6 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 132, n=52, 58, 47, 46 | 2 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 48, n=70, 78, 83, 65 | -2 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 96, n=59, 63, 52, 49 | 3 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 168, n=45, 48, 20, 36 | -6 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 132, n=50, 57, 64, 46 | -6 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 48, n=72, 78, 57, 64 | 1 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 168, n=45, 48, 20, 37 | -5 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 48, n=73, 78, 83, 65 | -6 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 168, n=45, 48, 7, 37 | 0 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 132, n=51, 58, 64, 46 | -2 units per liter (U/L) |
| FPV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 96, n=59, 63, 73, 49 | -4 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 96, n=59, 63, 52, 49 | 4 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 168, n=45, 48, 7, 37 | 2 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 48, n=73, 78, 83, 65 | -5 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 96, n=57, 63, 73, 49 | -4 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 132, n=50, 57, 64, 46 | -4 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 168, n=45, 48, 20, 36 | -6 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 48, n=70, 78, 83, 65 | -6 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 96, n=59, 63, 73, 49 | -3 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 132, n=51, 58, 64, 46 | -4 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 168, n=45, 48, 20, 37 | -5 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 48, n=72, 78, 57, 64 | 2 units per liter (U/L) |
| NFV Population (APV30001) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 132, n=52, 58, 47, 46 | 4 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 96, n=59, 63, 52, 49 | 0 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 96, n=59, 63, 73, 49 | 2 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 48, n=73, 78, 83, 65 | 1 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 132, n=51, 58, 64, 46 | 2 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 48, n=70, 78, 83, 65 | 2 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 168, n=45, 48, 20, 37 | 6 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 168, n=45, 48, 7, 37 | -5 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 48, n=72, 78, 57, 64 | 1 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 132, n=52, 58, 47, 46 | 1 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 132, n=50, 57, 64, 46 | 2 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 168, n=45, 48, 20, 36 | 2 units per liter (U/L) |
| FPV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 96, n=57, 63, 73, 49 | 1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 168, n=45, 48, 20, 36 | -1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 96, n=59, 63, 52, 49 | 3 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 132, n=52, 58, 47, 46 | 2 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 96, n=59, 63, 73, 49 | 1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 96, n=57, 63, 73, 49 | -1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 48, n=70, 78, 83, 65 | 0 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 48, n=72, 78, 57, 64 | 1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 132, n=51, 58, 64, 46 | 2 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | Serum lipase; Week 168, n=45, 48, 7, 37 | 3 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 48, n=73, 78, 83, 65 | 0 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | AST; Week 132, n=50, 57, 64, 46 | 1 units per liter (U/L) |
| NFV Population (APV30002) | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168 | ALT; Week 168, n=45, 48, 20, 37 | -3 units per liter (U/L) |
Primary
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time frame: Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Population: All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 8 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48 | 32 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0 | 4 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40 | 27 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34 | 25 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 52 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 10 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40 | 27 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 52 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44 | 9 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 12 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40 | 16 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 39 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40 | 12 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40 | 35 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 52 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40 | 13 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 42 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44 | 4 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59 | 7 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 56 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40 | 5 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 7 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37 | 25 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0 | 37 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 16 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40 | 17 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0 | 17 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59, | 10 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40 | 43 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 3 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40 | 33 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 15 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 54 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40 | -2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 6 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0 | 13 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40 | 4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40 | -2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40 | 6 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59, | -0.2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40 | -4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59 | -2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37 | -2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40 | 4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | -33 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0 | -5 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | -12 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | -36 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34 | 11 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 8 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48 | 10 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40 | 10 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40 | 5 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | -9 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 3 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44 | -48 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40 | 1 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40 | 5 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40 | NA milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | -41 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44 | 0 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40 | -0.9 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40 | 14 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0 | 1 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | -4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 5 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | -41 milligrams per deciliter (mg/dl) |
| NFV Population (APV30001) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | -3 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 53 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44 | 1.8 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40 | 2.7 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 50 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0 | 0 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40 | 12 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48 | 30 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 46 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40 | 5.4 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 12 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 43 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34 | 24 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40 | 21 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 47 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 51 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 37 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44 | 47 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 53 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40 | 23 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0 | 17 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40 | 17 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 17 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0 | 18 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40 | 22 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59 | 3.6 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40 | 1.8 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 53 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 47 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 43 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40 | 47 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 27 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59, | 8 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40 | 12 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40 | 15 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37 | 21 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40 | 21 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40 | 1.8 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 39 milligrams per deciliter (mg/dl) |
| FPV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40 | 47 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48 | 0 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40 | 9 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 9 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0 | 5 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0 | 12 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40 | -9 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 98 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | -4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40 | -2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40 | 18 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40 | 15 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37 | 1 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40 | 13 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59 | -4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59, | 3 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40 | 2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40 | 13 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0 | -2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34 | 4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 21 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44 | -5 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 10 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40 | 7 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40 | -1.8 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 8 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 22 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40 | 5 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40 | -4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 30 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 20 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 4 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40 | 10 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 19 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 12 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 18 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| NFV Population (APV30002) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44 | 15 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 4 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 18 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | -65 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 6 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40 | 6 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40 | -39 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44 | 0 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40 | 1 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 3 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | -3 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 9 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40 | 8 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40 | 6 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34 | -4 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 13 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 14 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 12 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59, | 6 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40 | -2 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40 | 7 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40 | -6 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40 | -14 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0 | -3 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | -7 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0 | 8 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 11 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 3 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40 | 14 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 29 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40 | 14 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44 | 16 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 13 milligrams per deciliter (mg/dl) |
| FPV/RTV QD Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37 | 3 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 22 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 9 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 11 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44 | 34 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40 | 3 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 22 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40 | 1 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40 | 18 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 66 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40 | 4 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40 | 4 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48 | -1 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37 | 0 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40 | 12 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 42 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40 | 5 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40 | 11 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44 | 4 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0 | -3 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 10 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 8 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59 | 7 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 28 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | 6 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59, | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 13 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 14 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40 | 2 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40 | 5 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40 | 4 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34 | -2 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 9 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 49 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40 | -4 milligrams per deciliter (mg/dl) |
| FPV/RTV BID Population (APV30003) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0 | -6 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40 | 5 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59, | 3 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | -5 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40 | 7 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0 | 21 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40 | 0 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40 | 2 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40 | 20 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 5 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59 | 0 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | -2 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40 | -7 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0 | -1 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | 12 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34 | 0 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 13 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 8 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 4 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 5 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40 | 12 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 13 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40 | 3 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 5 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48 | 3 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40 | 3 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40 | 6 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37 | 7 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40 | -45 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | -4 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44 | -5 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44 | 0 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 6 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0 | 10 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40 | 3 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40 | 21 milligrams per deciliter (mg/dl) |
| PI-Naïve Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 204, n=70, 11, 105, 22, 19, 19, 61,40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | 43 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 96, n=92, 13, 132, 34, 47, 52, 67, 44 | -5 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40 | -129 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44 | 7 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 168, n=71, 14, 123, 31, 31, 40, 0, 0 | 5 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 96, n=87, 12, 121, 34, 43, 43, 63, 37 | 15 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 48, n=50, 13, 145, 35, 53, 50, 67, 48 | 17 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 216, n=69, 0, 105, 2, 4, 10, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61,40 | 16 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | -73 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 216, n=75, 0, 110, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40 | 32 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 120, n=78, 13, 120, 29, 40, 39, 61,40 | 38 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 132, n=78, 12, 117, 29, 36, 37, 58,34 | 14 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40 | 12 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77 59, | 8 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 204, n=73, 10, 113, 23, 20, 26, 61,40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 132, n=82, 13, 128, 30, 40, 44, 61, 40 | -14 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | 28 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 5 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 120, n=84, 14, 136, 31, 44, 48, 61, 40 | -2 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44 | 19 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 180, n=73, 12, 112, 28, 33, 37, 61, 40 | -1 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61,40 | 18 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33 | -167 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 48, n=54, 14, 158, 36, 61, 65, 77, 59 | 0 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | 22 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 204, n=73, 12, 115, 23, 20, 26, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 180, n=67, 11, 111, 27, 29, 30, 61,40 | 54 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40 | -170 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | FBG; W 168, n=71, 14, 123, 29, 31, 40, 0, 0 | 0 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40 | NA milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59 | -54 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | LDL Chol.; W 168, n=63, 13, 115, 30, 28, 34, 0, 0 | 48 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | HDL Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61,40 | 10 milligrams per deciliter (mg/dl) |
| PI-Experienced Population (Other Studies) | Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216 | Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40 | NA milligrams per deciliter (mg/dl) |
Primary
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time frame: Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 204, n=73, 12, 113, 23 | -0.3 ratio |
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 120, n=84, 14, 137, 33 | -0.2 ratio |
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 216, n=76, 0, 111, 2 | -0.5 ratio |
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 180, n=73, 12, 114, 30 | -0.4 ratio |
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 48, n=54, 14, 159, 38 | 0.1 ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 180, n=73, 12, 114, 30 | -0.6 ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 204, n=73, 12, 113, 23 | -0.6 ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 216, n=76, 0, 111, 2 | NA ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 120, n=84, 14, 137, 33 | -0.6 ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 48, n=54, 14, 159, 38 | -0.4 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 180, n=73, 12, 114, 30 | -0.3 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 48, n=54, 14, 159, 38 | 0.4 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 120, n=84, 14, 137, 33 | -0.1 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 204, n=73, 12, 113, 23 | -0.4 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 216, n=76, 0, 111, 2 | -0.5 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 204, n=73, 12, 113, 23 | -0.4 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 120, n=84, 14, 137, 33 | -0.2 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 48, n=54, 14, 159, 38 | 0.1 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 180, n=73, 12, 114, 30 | -0.3 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216 | Week 216, n=76, 0, 111, 2 | 0.3 ratio |
Primary
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Time frame: Baseline (Day 1) and Weeks 48, 96, 132, and 168
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 48, n=61, 65 , 45, 7 | -0.4 ratio |
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 96, n=47, 52, 42, 5 | -0.5 ratio |
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 132, n=40, 44, 41, 4 | -0.4 ratio |
| FPV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 168, n=31, 40, 3, 5 | -0.3 ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 96, n=47, 52, 42, 5 | 0.1 ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 132, n=40, 44, 41, 4 | -0.6 ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 168, n=31, 40, 3, 5 | 0.2 ratio |
| NFV Population (APV30001) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 48, n=61, 65 , 45, 7 | -0.3 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 132, n=40, 44, 41, 4 | -0.2 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 96, n=47, 52, 42, 5 | -0.1 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 168, n=31, 40, 3, 5 | -0.6 ratio |
| FPV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 48, n=61, 65 , 45, 7 | -0.1 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 168, n=31, 40, 3, 5 | -1.4 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 96, n=47, 52, 42, 5 | -0.3 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 48, n=61, 65 , 45, 7 | -0.8 ratio |
| NFV Population (APV30002) | Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168 | Week 132, n=40, 44, 41, 4 | -1.5 ratio |
Primary
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.
Time frame: Weeks 120, 180, 204, 216, and 432
Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | AST; Week 120, n=14 | 18 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | AST; Week 180, n=14 | 21 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | AST; Week 204, n=107 | 20 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | AST; Week 216, n=106 | 21 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | ALT; Week 216, n=106 | 19 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | ALT; Week 432, n=41 | 19 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | Serum lipase;Week 120, n=14 | 47 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | Serum lipase; Week 180, n=14 | 39 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | Serum lipase; Week 204, n=107 | 34 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | Serum lipase; Week 216, n=106 | 36 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | Serum lipase; Week 432, n=41 | 36 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | AST; Week 432, n=41 | 21 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | ALT; Week 120, n=14 | 18 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | ALT; Week 180, n=14 | 32 units per liter (U/L) |
| FPV Population (APV30001) | Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432 | ALT; Week 204, n=107 | 19 units per liter (U/L) |
Primary
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
Time frame: Weeks 120, 180, 204, 216, and 432
Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 | Week 180, n=14 | 5.5 ratio |
| FPV Population (APV30001) | Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 | Week 204, n=106 | 3.7 ratio |
| FPV Population (APV30001) | Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 | Week 216, n=102 | 3.5 ratio |
| FPV Population (APV30001) | Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 | Week 432, n=40 | 4.0 ratio |
| FPV Population (APV30001) | Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432 | Week 120, n=14 | 5.5 ratio |
Primary
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
Time frame: Weeks 120, 180, 204, 216, and 432
Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Triglycerides; Week 120, n=14 | 237 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Triglycerides; Week 180, n=14 | 248 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Triglycerides; Week 204, n=106 | 137 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Triglycerides; Week 216, n=102 | 120 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Triglycerides; Week 432, n=40 | 132 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Cholesterol; Week 120, n=14 | 202 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Cholesterol; Week 180, n=14 | 206 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Cholesterol; Week 204, n=106 | 201 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Cholesterol; Week 216, n=102 | 205 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | Cholesterol; Week 432, n=40 | 192 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | HDL Cholesterol; Week 120, n=14 | 40 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | HDL Cholesterol; Week 180, n=14 | 36 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | HDL Cholesterol; Week 204, n=106 | 52 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | HDL Cholesterol; Week 216, n=102 | 51 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | HDL Cholesterol; Week 432, n=40 | 51 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | LDL Cholesterol; Week 120, n=14 | 40 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | LDL Cholesterol; Week 180, n=14 | 40 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | LDL Cholesterol; Week 204, n=106 | 52 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | LDL Cholesterol; Week 216, n=102 | 51 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | LDL Cholesterol; Week 432, n=40 | 51 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | FBG; Week 120, n=14 | 86 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | FBG; Week 180, n=14 | 88 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | FBG; Week 204, n=106 | 92 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | FBG; Week 216, n=104 | 90 milligrams per deciliter (mg/dl) |
| FPV Population (APV30001) | Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432 | FBG Cholesterol; Week 432, n=40 | 92 milligrams per deciliter (mg/dl) |
Primary
Number of Participants With Any Adverse Event (AE): Final Analysis
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section.
Time frame: Post January 2006; for up to 241 weeks
Population: All participants who remained in the study after January 31, 2006.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FPV Population (APV30001) | Number of Participants With Any Adverse Event (AE): Final Analysis | 95 participants |
Primary
Number of Participants With Any Adverse Event (AE): Interim Analysis
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the Other (Non-Serious) Adverse Events section.
Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Population: All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FPV Population (APV30001) | Number of Participants With Any Adverse Event (AE): Interim Analysis | 117 participants |
| NFV Population (APV30001) | Number of Participants With Any Adverse Event (AE): Interim Analysis | 16 participants |
| FPV Population (APV30002) | Number of Participants With Any Adverse Event (AE): Interim Analysis | 215 participants |
| NFV Population (APV30002) | Number of Participants With Any Adverse Event (AE): Interim Analysis | 52 participants |
| FPV/RTV QD Population (APV30003) | Number of Participants With Any Adverse Event (AE): Interim Analysis | 72 participants |
| FPV/RTV BID Population (APV30003) | Number of Participants With Any Adverse Event (AE): Interim Analysis | 75 participants |
| PI-Naïve Population (Other Studies) | Number of Participants With Any Adverse Event (AE): Interim Analysis | 95 participants |
| PI-Experienced Population (Other Studies) | Number of Participants With Any Adverse Event (AE): Interim Analysis | 68 participants |
Secondary
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Time frame: Baseline and Weeks 24, 48, 96, 132, and 168
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naїve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 24, n=71, 73, 92, 75 | 367 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 168, n=40, 47, 20, 39 | 513 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 48, n=73, 77, 85, 68 | 374 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 132, n=50, 56, 64, 47 | 395 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 96, n=58, 62, 73, 50 | 409 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Baseline, n=72, 78, 94, 76 | 311 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Baseline, n=72, 78, 94, 76 | 304 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 168, n=40, 47, 20, 39 | 409 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 24, n=71, 73, 92, 75 | 348 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 132, n=50, 56, 64, 47 | 386 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 48, n=73, 77, 85, 68 | 386 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 96, n=58, 62, 73, 50 | 417 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 48, n=73, 77, 85, 68 | 582 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Baseline, n=72, 78, 94, 76 | 477 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 168, n=40, 47, 20, 39 | 619 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 132, n=50, 56, 64, 47 | 642 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 24, n=71, 73, 92, 75 | 520 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 96, n=58, 62, 73, 50 | 567 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 168, n=40, 47, 20, 39 | 460 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 132, n=50, 56, 64, 47 | 486 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Baseline, n=72, 78, 94, 76 | 361 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 24, n=71, 73, 92, 75 | 399 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 48, n=73, 77, 85, 68 | 418 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis | Week 96, n=58, 62, 73, 50 | 463 cells per millimeters cubed (cells/mm^3) |
Secondary
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Time frame: Baseline and Weeks 48, 120, 168, 180, 204, and 216
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 180, n=78, 9, 153, 33 | 541 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 120, n=95, 15, 177, 40 | 512 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 48, n=117, 17, 211, 49 | 426 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 216, n=77, 0, 138, 4 | 608 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 168, n=81, 12, 160, 37 | 594 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Baseline, n=119, 18, 219, 52 | 211 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 204, n=75, 11, 145, 27 | 535 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 120, n=95, 15, 177, 40 | 613 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 180, n=78, 9, 153, 33 | 447 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Baseline, n=119, 18, 219, 52 | 505 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 48, n=117, 17, 211, 49 | 499 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 168, n=81, 12, 160, 37 | 608 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 204, n=75, 11, 145, 27 | 563 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30001) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 216, n=77, 0, 138, 4 | NA cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Baseline, n=119, 18, 219, 52 | 167 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 120, n=95, 15, 177, 40 | 475 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 204, n=75, 11, 145, 27 | 494 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 168, n=81, 12, 160, 37 | 506 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 180, n=78, 9, 153, 33 | 494 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 216, n=77, 0, 138, 4 | 534 cells per millimeters cubed (cells/mm^3) |
| FPV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 48, n=117, 17, 211, 49 | 396 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Baseline, n=119, 18, 219, 52 | 297 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 180, n=78, 9, 153, 33 | 413 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 120, n=95, 15, 177, 40 | 439 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 216, n=77, 0, 138, 4 | 548 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 204, n=75, 11, 145, 27 | 459 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 48, n=117, 17, 211, 49 | 377 cells per millimeters cubed (cells/mm^3) |
| NFV Population (APV30002) | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis | Week 168, n=81, 12, 160, 37 | 422 cells per millimeters cubed (cells/mm^3) |
Secondary
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Time frame: Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 72, n=65, 73, 80, 53 | 1.72 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 96, n=60, 62, 75, 51 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 168, n=44, 48, 20, 39 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 24, n=73, 75, 93, 79 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 12, n=69, 78, 92, 79 | 1.7 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Baseline, n=73, 78, 92, 82 | 3.96 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 132, n=50, 58, 65, 46 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 48, n=73, 77, 85, 68 | 1.71 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 12, n=69, 78, 92, 79 | 1.81 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 96, n=60, 62, 75, 51 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 72, n=65, 73, 80, 53 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 168, n=44, 48, 20, 39 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Baseline, n=73, 78, 92, 82 | 4.06 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 48, n=73, 77, 85, 68 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 132, n=50, 58, 65, 46 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 24, n=73, 75, 93, 79 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 48, n=73, 77, 85, 68 | 1.7 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 168, n=44, 48, 20, 39 | 1.7 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Baseline, n=73, 78, 92, 82 | 1.7 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 12, n=69, 78, 92, 79 | 1.7 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 24, n=73, 75, 93, 79 | 1.7 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 72, n=65, 73, 80, 53 | 1.7 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 96, n=60, 62, 75, 51 | 1.7 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 132, n=50, 58, 65, 46 | 1.7 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Baseline, n=73, 78, 92, 82 | 1.81 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 96, n=60, 62, 75, 51 | 1.7 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 24, n=73, 75, 93, 79 | 1.9 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 12, n=69, 78, 92, 79 | 2.03 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 168, n=44, 48, 20, 39 | 1.7 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 132, n=50, 58, 65, 46 | 1.7 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 72, n=65, 73, 80, 53 | 1.7 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168 | Week 48, n=73, 77, 85, 68 | 1.7 log 10 copies per milliliter |
Secondary
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Time frame: Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 120, n=96, 15, 183, 40 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 24, n=119, 17, 217, 51 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 180, n=82, 12, 159, 34 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 144, n=89, 15, 173, 39 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 168, n=81, 14, 160, 38 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Baseline, n=119, 18, 221, 54 | 4.82 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 216, n=80, 0, 143, 4 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 48, n=118, 17, 218, 49 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 72, n=113, 15, 204, 46 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 96, n=106, 15, 192, 43 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 204, n=78, 12, 153, 27 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 48, n=118, 17, 218, 49 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 120, n=96, 15, 183, 40 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Baseline, n=119, 18, 221, 54 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 144, n=89, 15, 173, 39 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 96, n=106, 15, 192, 43 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 24, n=119, 17, 217, 51 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 168, n=81, 14, 160, 38 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 72, n=113, 15, 204, 46 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 180, n=82, 12, 159, 34 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 204, n=78, 12, 153, 27 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30001) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 216, n=80, 0, 143, 4 | NA log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 204, n=78, 12, 153, 27 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Baseline, n=119, 18, 221, 54 | 4.82 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 24, n=119, 17, 217, 51 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 48, n=118, 17, 218, 49 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 72, n=113, 15, 204, 46 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 96, n=106, 15, 192, 43 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 120, n=96, 15, 183, 40 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 144, n=89, 15, 173, 39 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 168, n=81, 14, 160, 38 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 180, n=82, 12, 159, 34 | 1.69 log 10 copies per milliliter |
| FPV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 216, n=80, 0, 143, 4 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 120, n=96, 15, 183, 40 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 216, n=80, 0, 143, 4 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 180, n=82, 12, 159, 34 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 96, n=106, 15, 192, 43 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 72, n=113, 15, 204, 46 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 48, n=118, 17, 218, 49 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 204, n=78, 12, 153, 27 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 24, n=119, 17, 217, 51 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 144, n=89, 15, 173, 39 | 1.69 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Baseline, n=119, 18, 221, 54 | 1.78 log 10 copies per milliliter |
| NFV Population (APV30002) | Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216 | Week 168, n=81, 14, 160, 38 | 1.69 log 10 copies per milliliter |
Secondary
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Time frame: Weeks 180, 240, 300, 360, 420, and 432
Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 | Week 360, n=53 | 1.7 log 10 copies per milliliters |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 | Week 420, n=52 | 1.7 log 10 copies per milliliters |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 | Week 180, n=14 | 1.7 log 10 copies per milliliters |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 | Week 240, n=101 | 1.7 log 10 copies per milliliters |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 | Week 300, n=82 | 1.7 log 10 copies per milliliters |
| FPV Population (APV30001) | Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432 | Week 432, n=41 | 1.7 log 10 copies per milliliters |
Secondary
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.
Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Population: All participants receiving FPV or NFV in Studies APV30001 and APV30002.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Pneumocystis carinii pneumonia | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Cytomegalovirus retinitis | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Peripheral neuropathy | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Cervical dysplasia | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Mycobacterium avium complex/ M kansaii | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Hairy leukoplakia, oral | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Fever lasting >1 month | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Progressive multifocal leukoencephalopathy | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Lymphoma,immunoblastic | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Kaposis's sarcoma, cutaneous | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Herpes zoster | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Toxoplasmosis of brain | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Encepathopathy, HIV-related | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Candidiasis, oropharyngeal | 4 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Diarrhea lasting >1 month | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Non-CDC HIV-associated conditions | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Mycobacterium tuberculosis, any site | 0 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Herpes simplex | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Candidiasis, vulvovaginal | 1 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Mycobacterium tuberculosis, any site | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Toxoplasmosis of brain | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Candidiasis, oropharyngeal | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Herpes zoster | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Diarrhea lasting >1 month | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Candidiasis, vulvovaginal | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Cervical dysplasia | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Fever lasting >1 month | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Hairy leukoplakia, oral | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Peripheral neuropathy | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Cytomegalovirus retinitis | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Herpes simplex | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Encepathopathy, HIV-related | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Kaposis's sarcoma, cutaneous | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Lymphoma,immunoblastic | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Mycobacterium avium complex/ M kansaii | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Pneumocystis carinii pneumonia | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Progressive multifocal leukoencephalopathy | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Non-CDC HIV-associated conditions | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Mycobacterium tuberculosis, any site | 2 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Lymphoma,immunoblastic | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Cytomegalovirus retinitis | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Herpes zoster | 3 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Encepathopathy, HIV-related | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Mycobacterium avium complex/ M kansaii | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Non-CDC HIV-associated conditions | 8 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Diarrhea lasting >1 month | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Toxoplasmosis of brain | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Fever lasting >1 month | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Progressive multifocal leukoencephalopathy | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Cervical dysplasia | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Kaposis's sarcoma, cutaneous | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Hairy leukoplakia, oral | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Herpes simplex | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Candidiasis, oropharyngeal | 7 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Pneumocystis carinii pneumonia | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Peripheral neuropathy | 2 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Candidiasis, vulvovaginal | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Peripheral neuropathy | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Pneumocystis carinii pneumonia | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Cytomegalovirus retinitis | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Diarrhea lasting >1 month | 2 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Encepathopathy, HIV-related | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Herpes simplex | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Herpes zoster | 3 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Mycobacterium tuberculosis, any site | 1 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Candidiasis, oropharyngeal | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Kaposis's sarcoma, cutaneous | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Progressive multifocal leukoencephalopathy | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Lymphoma,immunoblastic | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Toxoplasmosis of brain | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Mycobacterium avium complex/ M kansaii | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Cervical dysplasia | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Fever lasting >1 month | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Non-CDC HIV-associated conditions | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Hairy leukoplakia, oral | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions | Candidiasis, vulvovaginal | 0 participants |
Secondary
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
The number of participants with the indicated HIV-associated conditions were assessed.
Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Population: All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Candidiasis, oropharyngeal | 5 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Mycobacterium tuberculosis, any site | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Herpes Zoster | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Hairy leukoplakia, oral | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Other, Non-CDC HIV associated condition | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Peripheral neuropathy | 1 participants |
| FPV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Diarrhea lasting >1 month | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Mycobacterium tuberculosis, any site | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Diarrhea lasting >1 month | 1 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Peripheral neuropathy | 1 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Herpes Zoster | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Other, Non-CDC HIV associated condition | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Hairy leukoplakia, oral | 0 participants |
| NFV Population (APV30001) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Candidiasis, oropharyngeal | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Diarrhea lasting >1 month | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Candidiasis, oropharyngeal | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Hairy leukoplakia, oral | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Peripheral neuropathy | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Herpes Zoster | 1 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Mycobacterium tuberculosis, any site | 0 participants |
| FPV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Other, Non-CDC HIV associated condition | 1 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Peripheral neuropathy | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Other, Non-CDC HIV associated condition | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Mycobacterium tuberculosis, any site | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Hairy leukoplakia, oral | 1 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Candidiasis, oropharyngeal | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Herpes Zoster | 0 participants |
| NFV Population (APV30002) | Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions | Diarrhea lasting >1 month | 0 participants |
Secondary
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.
Time frame: Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Population: All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Population (APV30001) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class C to new CDC class C | 1 participants |
| FPV Population (APV30001) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class B to CDC class C | 3 participants |
| FPV Population (APV30001) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A, B, or C to death (on treatment) | 0 participants |
| FPV Population (APV30001) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A to CDC class C | 0 participants |
| NFV Population (APV30001) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A, B, or C to death (on treatment) | 0 participants |
| NFV Population (APV30001) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A to CDC class C | 0 participants |
| NFV Population (APV30001) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class C to new CDC class C | 0 participants |
| NFV Population (APV30001) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class B to CDC class C | 0 participants |
| FPV Population (APV30002) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A, B, or C to death (on treatment) | 3 participants |
| FPV Population (APV30002) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A to CDC class C | 3 participants |
| FPV Population (APV30002) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class C to new CDC class C | 2 participants |
| FPV Population (APV30002) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class B to CDC class C | 5 participants |
| NFV Population (APV30002) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class B to CDC class C | 3 participants |
| NFV Population (APV30002) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class C to new CDC class C | 2 participants |
| NFV Population (APV30002) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A to CDC class C | 0 participants |
| NFV Population (APV30002) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A, B, or C to death (on treatment) | 1 participants |
| FPV/RTV QD Population (APV30003) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A to CDC class C | 0 participants |
| FPV/RTV QD Population (APV30003) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class C to new CDC class C | 0 participants |
| FPV/RTV QD Population (APV30003) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class B to CDC class C | 1 participants |
| FPV/RTV QD Population (APV30003) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A, B, or C to death (on treatment) | 0 participants |
| FPV/RTV BID Population (APV30003) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A, B, or C to death (on treatment) | 0 participants |
| FPV/RTV BID Population (APV30003) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A to CDC class C | 1 participants |
| FPV/RTV BID Population (APV30003) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class B to CDC class C | 0 participants |
| FPV/RTV BID Population (APV30003) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class C to new CDC class C | 0 participants |
| PI-Naïve Population (Other Studies) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A to CDC class C | 0 participants |
| PI-Naïve Population (Other Studies) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class B to CDC class C | 0 participants |
| PI-Naïve Population (Other Studies) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A, B, or C to death (on treatment) | 0 participants |
| PI-Naïve Population (Other Studies) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class C to new CDC class C | 0 participants |
| PI-Experienced Population (Other Studies) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class B to CDC class C | 1 participants |
| PI-Experienced Population (Other Studies) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A to CDC class C | 0 participants |
| PI-Experienced Population (Other Studies) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class A, B, or C to death (on treatment) | 0 participants |
| PI-Experienced Population (Other Studies) | Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline | CDC class C to new CDC class C | 1 participants |
Secondary
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Time frame: Baseline and Weeks 48, 120, 180, and 216
Population: All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <400 copies, n=119, 219, 54; MD=F | 66 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <50 copies, n=119, 219, 54; MD=F | 80 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <400 copies, n=82, 158, 34; observed | 95 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <400 copies, n=119, 219, 54; MD=F | 1 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <400 copies, n=80, 142, 0; observed | 93 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <50 copies, n=82, 158, 34; observed | 88 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <50 copies, n=80, 142, 0; observed | 86 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <50 copies, n=119, 219, 54; MD=F | 1 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <50 copies, n=118, 216, 49; observed | 81 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <50 copies, n=119, 219, 0; MD=F | 58 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <400 copies, n=119, 219, 0; MD=F | 62 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <400 copies, n=119, 219, 54; MD=F | 76 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <50 copies, n=119, 219, 54; observed | 1 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <400 copies, n=119, 219, 54; observed | 1 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <400 copies, n=119, 219, 54; MD=F | 92 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <50 copies, n=119, 219, 54; MD=F | 61 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <400 copies, n=118, 216, 49; observed | 93 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <50 copies, n=96, 181, 40; observed | 88 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <50 copies, n=119, 219, 54; MD=F | 71 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <400 copies, n=96, 181, 40; observed | 95 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <400 copies, n=119, 219, 54; observed | 0 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <400 copies, n=119, 219, 54; MD=F | 94 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <400 copies, n=119, 219, 54; MD=F | 77 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <400 copies, n=119, 219, 54; MD=F | 68 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <400 copies, n=119, 219, 0; MD=F | 61 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <400 copies, n=119, 219, 54; MD=F | 0 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <400 copies, n=118, 216, 49; observed | 95 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <400 copies, n=96, 181, 40; observed | 93 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <400 copies, n=80, 142, 0; observed | 94 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <50 copies, n=119, 219, 54; MD=F | 0 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <50 copies, n=119, 219, 54; MD=F | 76 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <400 copies, n=82, 158, 34; observed | 94 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <50 copies, n=119, 219, 54; MD=F | 66 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <50 copies, n=119, 219, 54; MD=F | 63 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <50 copies, n=119, 219, 0; MD=F | 58 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <50 copies, n=119, 219, 54; observed | 0 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <50 copies, n=118, 216, 49; observed | 77 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <50 copies, n=96, 181, 40; observed | 80 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <50 copies, n=82, 158, 34; observed | 88 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <50 copies, n=80, 142, 0; observed | 89 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <400 copies, n=119, 219, 54; MD=F | 69 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <400 copies, n=119, 219, 54; observed | 61 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <50 copies, n=82, 158, 34; observed | 76 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <50 copies, n=119, 219, 54; MD=F | 48 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <50 copies, n=96, 181, 40; observed | 83 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <50 copies, n=119, 219, 0; MD=F | NA percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <400 copies, n=119, 219, 0; MD=F | NA percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <400 copies, n=119, 219, 54; MD=F | 61 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <50 copies, n=119, 219, 54; observed | 46 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <400 copies, n=119, 219, 54; MD=F | 54 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <50 copies, n=80, 142, 0; observed | NA percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <50 copies, n=119, 219, 54; MD=F | 61 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Baseline <50 copies, n=119, 219, 54; MD=F | 46 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 216 <400 copies, n=80, 142, 0; observed | NA percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 180 <400 copies, n=82, 158, 34; observed | 85 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <50 copies, n=118, 216, 49; observed | 65 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <400 copies, n=119, 219, 54; MD=F | 85 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 120 <400 copies, n=96, 181, 40; observed | 93 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <50 copies, n=119, 219, 54; MD=F | 59 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed) | Week 48 <400 copies, n=118, 216, 49; observed | 94 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.
Time frame: Baseline and Weeks 12, 24, 48, 60, 96, and 132
Population: All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <400 copies, n=73, 78, 104, 86; MD=F | 49 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <50 copies, n=73, 75, 93, 79; observed | 63 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <400 copies, n=60, 62, 75, 51; observed | 70 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <400 copies, n=71, 76, 81, 58; observed | 72 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <400 copies, n=73, 78, 92, 82; observed | 0 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <400 copies, n=73, 78, 104, 86; MD=F | 75 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <400 copies, n=73, 77, 85, 68; observed | 71 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <400 copies, n=73, 75, 93, 79; observed | 79 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <400 copies, n=69, 78, 92, 79; observed | 80 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <50 copies, n=60, 62, 75, 51; observed | 55 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <50 copies, n=69, 78, 92, 79; observed | 49 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <50 copies, n=73, 78, 92, 82; observed | 0 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <400 copies, n=73, 78, 104, 86; MD=F | 79 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <50 copies, n=71, 76, 81, 58; observed | 52 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <50 copies, n=73, 78, 104, 86; MD=F | 37 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <50 copies, n=73, 78, 104, 86; MD=F | 45 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <400 copies, n=73, 78, 104, 86; MD=F | 71 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <400 copies, n=73, 78, 104, 86; MD=F | 0 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <50 copies, n=73, 78, 104, 86; MD=F | 51 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <50 copies, n=73, 78, 104, 86; MD=F | 49 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <400 copies, n=73, 78, 104, 86; MD=F | 70 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <50 copies, n=50, 58, 65, 46; observed | 54 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <50 copies, n=73, 78, 104, 86; MD=F | 63 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <50 copies, n=73, 78, 104, 86; MD=F | 47 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <400 copies, n=73, 78, 104, 86; MD=F | 58 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <50 copies, n=73, 77, 85, 68; observed | 49 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <50 copies, n=73, 78, 104, 86; MD=F | 0 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <400 copies,n=50, 58, 65, 46; observed | 72 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <50 copies, n=73, 78, 104, 86; MD=F | 45 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <400 copies, n=73, 78, 104, 86; MD=F | 1 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <400 copies, n=73, 78, 104, 86; MD=F | 82 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <400 copies, n=73, 78, 104, 86; MD=F | 79 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <400 copies, n=73, 78, 104, 86; MD=F | 78 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <400 copies, n=73, 78, 104, 86; MD=F | 77 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <400 copies, n=73, 78, 104, 86; MD=F | 62 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <400 copies, n=73, 78, 104, 86; MD=F | 60 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <400 copies, n=73, 78, 92, 82; observed | 1 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <400 copies, n=69, 78, 92, 79; observed | 82 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <400 copies, n=73, 75, 93, 79; observed | 83 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <400 copies, n=73, 77, 85, 68; observed | 79 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <400 copies, n=71, 76, 81, 58; observed | 79 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <400 copies, n=60, 62, 75, 51; observed | 77 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <400 copies,n=50, 58, 65, 46; observed | 81 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <50 copies, n=73, 78, 104, 86; MD=F | 0 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <50 copies, n=73, 78, 104, 86; MD=F | 47 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <50 copies, n=73, 78, 104, 86; MD=F | 64 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <50 copies, n=73, 78, 104, 86; MD=F | 60 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <50 copies, n=73, 78, 104, 86; MD=F | 59 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <50 copies, n=73, 78, 104, 86; MD=F | 51 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <50 copies, n=73, 78, 92, 82; observed | 0 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <50 copies, n=69, 78, 92, 79; observed | 47 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <50 copies, n=73, 75, 93, 79; observed | 67 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <50 copies, n=73, 77, 85, 68; observed | 61 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <50 copies, n=71, 76, 81, 58; observed | 61 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <50 copies, n=60, 62, 75, 51; observed | 65 percentage of participants |
| NFV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <50 copies, n=50, 58, 65, 46; observed | 60 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <50 copies, n=73, 78, 104, 86; MD=F | 53 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <50 copies, n=71, 76, 81, 58; observed | 88 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <50 copies, n=73, 78, 104, 86; MD=F | 69 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <50 copies, n=50, 58, 65, 46; observed | 85 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <50 copies, n=73, 78, 92, 82; observed | 66 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <400 copies, n=73, 78, 104, 86; MD=F | 74 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <400 copies, n=73, 78, 104, 86; MD=F | 82 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <50 copies, n=60, 62, 75, 51; observed | 84 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <50 copies, n=69, 78, 92, 79; observed | 88 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <400 copies, n=73, 78, 104, 86; MD=F | 78 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <400 copies, n=69, 78, 92, 79; observed | 92 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <400 copies,n=50, 58, 65, 46; observed | 95 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <50 copies, n=73, 78, 104, 86; MD=F | 68 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <50 copies, n=73, 78, 104, 86; MD=F | 78 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <400 copies, n=73, 75, 93, 79; observed | 95 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <50 copies, n=73, 78, 104, 86; MD=F | 59 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <400 copies, n=73, 78, 92, 82; observed | 95 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <50 copies, n=73, 75, 93, 79; observed | 87 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <400 copies, n=73, 77, 85, 68; observed | 95 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <50 copies, n=73, 78, 104, 86; MD=F | 61 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <400 copies, n=73, 78, 104, 86; MD=F | 67 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <400 copies, n=73, 78, 104, 86; MD=F | 84 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <400 copies, n=71, 76, 81, 58; observed | 95 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <400 copies, n=73, 78, 104, 86; MD=F | 85 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <400 copies, n=73, 78, 104, 86; MD=F | 60 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <50 copies, n=73, 78, 104, 86; MD=F | 78 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <400 copies, n=60, 62, 75, 51; observed | 93 percentage of participants |
| FPV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <50 copies, n=73, 77, 85, 68; observed | 85 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <400 copies, n=73, 78, 104, 86; MD=F | 45 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <400 copies,n=50, 58, 65, 46; observed | 76 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <50 copies, n=73, 77, 85, 68; observed | 53 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <50 copies, n=73, 78, 104, 86; MD=F | 44 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <400 copies, n=73, 78, 104, 86; MD=F | 51 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <50 copies, n=73, 75, 93, 79; observed | 46 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <50 copies, n=73, 78, 104, 86; MD=F | 40 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <50 copies, n=50, 58, 65, 46; observed | 74 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <50 copies, n=73, 78, 104, 86; MD=F | 42 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <400 copies, n=73, 78, 104, 86; MD=F | 50 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <50 copies, n=73, 78, 104, 86; MD=F | 42 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <50 copies, n=71, 76, 81, 58; observed | 60 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <50 copies, n=73, 78, 104, 86; MD=F | 41 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <400 copies, n=73, 78, 104, 86; MD=F | 60 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <50 copies, n=73, 78, 104, 86; MD=F | 37 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <50 copies, n=73, 78, 104, 86; MD=F | 40 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <400 copies, n=73, 78, 104, 86; MD=F | 52 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <50 copies, n=73, 78, 92, 82; observed | 46 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <50 copies, n=69, 78, 92, 79; observed | 43 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 12 <400 copies, n=69, 78, 92, 79; observed | 57 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <400 copies, n=73, 78, 92, 82; observed | 62 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Baseline <400 copies, n=73, 78, 104, 86; MD=F | 59 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 24 <400 copies, n=73, 75, 93, 79; observed | 66 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <50 copies, n=60, 62, 75, 51; observed | 63 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 48 <400 copies, n=73, 77, 85, 68; observed | 63 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 132 <400 copies, n=73, 78, 104, 86; MD=F | 41 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 60 <400 copies, n=71, 76, 81, 58; observed | 76 percentage of participants |
| NFV Population (APV30002) | Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed) | Week 96 <400 copies, n=60, 62, 75, 51; observed | 76 percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.
Time frame: Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432
Population: All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) | Week 300 <50 copies, n=82; observed | 93 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) | Week 120 <50 copies, n=14; observed | 93 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) | Week 180 <50 copies, n=14; observed | 86 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) | Week 240 <50 copies, n=101; observed | 87 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) | Week 360 <50 copies, n=53; observed | 89 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) | Week 420 <50 copies, n=52; observed | 92 percentage of participants |
| FPV Population (APV30001) | Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed) | Week 432 <50 copies, n=41; observed | 93 percentage of participants |