HIV Infection, Infection, Human Immunodeficiency Virus
Conditions
Keywords
HIV-1 LEXIVA Ritonavir Once-daily
Brief summary
This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.
Detailed description
A Phase IIIB, randomized, open-label, parallel group, multi-center, non-inferiority, 24-week study to evaluate the safety, efficacy and tolerability of switching from a 200mg ritonavir-boosted regimen of LEXIVA (700mg/100mg BID or 1400mg/200mg QD) to a once-daily, 100mg ritonavir-boosted regimen of LEXIVA (1400mg/100mg QD)
Interventions
DRUGHalf-boosted Fosamprenavir
Once daily, reduced dose ritonavir-boosted fosamprenavir
DRUGFull Boosted Fosamprenavir
Full ritonavir-boosted fosamprenavir
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with HIV-1 infection. * Are willing and able to understand and provide written consent prior to participation in this study.
Exclusion criteria
* Are pregnant or breastfeeding. * Have an active AIDS condition, pancreatitis, poor kidney function, or clinically relevant hepatitis. * Have certain medical conditions that may make participation unsafe. * Take medication that may interact with the study medication. * Have a history of allergy to any of the study drugs or any excipients therein. * Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 | Week 24 | Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis | Week 24 | A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants plasma with HIV-1 RNA \<50 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata. |
| Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis | Baseline and Week 24 | A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. Change from baseline was defined as plasma HIV-1 RNA level at Week 24 minus plasma HIV-1 RNA level at baseline. |
| Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis | Baseline and Week 24 | A blood sample was drawn to determine the CD4+ cell count at week 24. Change from baseline was defined as CD4+ cell count at Week 24 minus CD4+ cell count at baseline. |
| Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Baseline through Week 24 | The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event. Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis | Week 24 | A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants with plasma HIV-1 RNA \<400 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata. |
| Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 | Baseline and Week 24 | A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%. |
| Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24 | Baseline and Week 24 | A blood sample was drawn to determine the LDL level at Week 24. Percent change in LDL was defined as (LDL level at Week 24 minus level at baseline) divided by level at baseline x 100%. |
| Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline | Baseline through Week 24 | A blood sample was drawn for subjects failing to respond to therapy and the mutations present in the virus were identified. For each subject, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class. |
| Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Weeks 12 and 24 | Blood samples were drawn at weeks 12 and 24 to determine the plasma levels of APV and RTV. Concentration at the end of the dosing interval at steady state (Ctau) was presented. |
| Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Baseline through Week 24 | The number of participants who experienced any grades 2 to 4 adverse events was tabulated. Adverse events were graded based on the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. |
Countries
Puerto Rico, United States
Participant flow
Pre-assignment details
Participants were stratified prior to randomization according to baseline regimen (700 milligrams \[mg\]/100 mg twice a day \[BID\] or 1400 mg/200 mg once a day \[QD\]) and previous regimen (no other prior protease inhibitor \[PI\], non-boosted PI, or boosted PI). Results are reported for the 209 participants (out of 211 enrolled) receiving study drug.
Participants by arm
| Arm | Count |
|---|---|
| FPV/r100 Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD) | 140 |
| FPV/r200 FPV/RTV (either 700mg/100mg twice a day \[BID\] or 1400mg/200mg QD) | 69 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non-compliance | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Total | FPV/r100 | FPV/r200 |
|---|---|---|---|
| Age Continuous | 44.7 years STANDARD_DEVIATION 10 | 44.9 years STANDARD_DEVIATION 10.52 | 44.3 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 31 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 167 Participants | 109 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American/African heritage | 62 participants | 42 participants | 20 participants |
| Race/Ethnicity, Customized American Indian/Alaskan native | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian - South East Asian | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Mixed race | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White - Arabic/North African | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European | 139 participants | 95 participants | 44 participants |
| Sex: Female, Male Female | 42 Participants | 33 Participants | 9 Participants |
| Sex: Female, Male Male | 167 Participants | 107 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / — | 6 / — |
| serious Total, serious adverse events | 7 / — | 1 / — |
Outcome results
Primary
Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24
Virologic failure was defined as two consecutive plasma HIV-1 RNA measures greater than 400 copies/milliliter (mL) separated by at least 2 to 4 week. The percentage of participants not meeting the virologic failure definition was estimated with stratification by the six randomization strata using Mantel-Haenszel weights and the missing/discontinuation equals failure (MD=F) analysis. Missing/discontinuation values were considered failures.
Time frame: Week 24
Population: Intent-to-Treat Exposed (ITT-E) Population. Subjects who received at least one dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FPV/r100 | Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 | 92.1 Percentage of participants |
| FPV/r200 | Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 | 94.2 Percentage of participants |
95% CI: [-9.36, 5.12]
Secondary
Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis
A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. Change from baseline was defined as plasma HIV-1 RNA level at Week 24 minus plasma HIV-1 RNA level at baseline.
Time frame: Baseline and Week 24
Population: ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPV/r100 | Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis | -0.015 log10 copies/mL | Standard Deviation 0.388 |
| FPV/r200 | Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis | -0.022 log10 copies/mL | Standard Deviation 0.13 |
Secondary
Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis
A blood sample was drawn to determine the CD4+ cell count at week 24. Change from baseline was defined as CD4+ cell count at Week 24 minus CD4+ cell count at baseline.
Time frame: Baseline and Week 24
Population: ITT-E Population - Observed Analysis, available data from those subjects who had values at baseline and at Week 24
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| FPV/r100 | Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis | 11.5 cells/mm3 | Full Range 0.073 |
| FPV/r200 | Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis | 15 cells/mm3 | Full Range 0.194 |
Secondary
Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24
The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event. Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Baseline through Week 24
Population: Safety Population: all randomized subjects who consumed at least one dose of study drug and was analyzed according to the treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/r100 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Any event | 2 participants |
| FPV/r100 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Metastatic neoplasms | 1 participants |
| FPV/r100 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Aspartate aminotransferase increased | 1 participants |
| FPV/r100 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Central nervous system lesion | 1 participants |
| FPV/r100 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Alanine aminotransferase increased | 1 participants |
| FPV/r200 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Central nervous system lesion | 0 participants |
| FPV/r200 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Alanine aminotransferase increased | 0 participants |
| FPV/r200 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Any event | 0 participants |
| FPV/r200 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Aspartate aminotransferase increased | 0 participants |
| FPV/r200 | Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 | Metastatic neoplasms | 0 participants |
Secondary
Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24
The number of participants who experienced any grades 2 to 4 adverse events was tabulated. Adverse events were graded based on the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events.
Time frame: Baseline through Week 24
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Bronchitis | 3 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Nausea | 3 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Sinusitis | 3 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Upper respiratory tract infection | 4 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Blood glucose increased | 3 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Insomnia | 0 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Any event | 48 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Diarrhea | 8 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Depression | 1 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Headache | 1 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Influenza | 1 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Low density lipoprotein increased | 3 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Nasopharyngitis | 3 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Otitis media | 1 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Back pain | 0 participants |
| FPV/r100 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Hypercholesterolemia | 0 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Insomnia | 2 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Bronchitis | 3 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Depression | 2 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Nausea | 1 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Nasopharyngitis | 0 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Sinusitis | 1 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Headache | 2 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Upper respiratory tract infection | 0 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Back pain | 2 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Blood glucose increased | 0 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Hypercholesterolemia | 2 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Influenza | 2 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Otitis media | 2 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Any event | 24 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Low density lipoprotein increased | 0 participants |
| FPV/r200 | Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 | Diarrhea | 2 participants |
Secondary
Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline
A blood sample was drawn for subjects failing to respond to therapy and the mutations present in the virus were identified. For each subject, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class.
Time frame: Baseline through Week 24
Population: Participants in the ITT-E Population who met the virologic failure definition
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FPV/r200 | Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline | 0 Participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis
A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants plasma with HIV-1 RNA \<50 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.
Time frame: Week 24
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/r100 | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis | HIV-1 RNA greater than or equal to 50 copies/mL | 17.1 Percentage of participants |
| FPV/r100 | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis | Plasma HIV-1 RNA <50 copies/mL | 82.9 Percentage of participants |
| FPV/r200 | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis | HIV-1 RNA greater than or equal to 50 copies/mL | 15.4 Percentage of participants |
| FPV/r200 | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis | Plasma HIV-1 RNA <50 copies/mL | 84.6 Percentage of participants |
Secondary
Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis
A blood sample was drawn to determine the amount of plasma HIV-1 RNA virus in copies/mL at week 24. The percentage of participants with plasma HIV-1 RNA \<400 copies/mL at Week 24 were determined by the TLOVR algorithm with stratification by the six randomization strata.
Time frame: Week 24
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/r100 | Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis | Plasma HIV-1 RNA <400 copies/mL | 92 Percentage of participants |
| FPV/r100 | Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis | HIV-1 RNA greater than or equal to 400 copies/mL | 8 Percentage of participants |
| FPV/r200 | Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis | Plasma HIV-1 RNA <400 copies/mL | 94.2 Percentage of participants |
| FPV/r200 | Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis | HIV-1 RNA greater than or equal to 400 copies/mL | 5.8 Percentage of participants |
Secondary
Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24
A blood sample was drawn to determine the LDL level at Week 24. Percent change in LDL was defined as (LDL level at Week 24 minus level at baseline) divided by level at baseline x 100%.
Time frame: Baseline and Week 24
Population: Safety Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FPV/r100 | Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24 | 0 Percent change |
| FPV/r200 | Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24 | 2.1 Percent change |
Secondary
Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24
A blood sample was drawn to determine the cholesterol, HDL, triglycerides levels at Week 24. Percent change in total blood cholesterol, HDL, and triglycerides was defined as (lipid level at Week 24 minus level at baseline) divided by level at baseline x 100%.
Time frame: Baseline and Week 24
Population: Safety Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/r100 | Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 | Total cholesterol | -0.5 Percent change |
| FPV/r100 | Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 | HDL | -2.1 Percent change |
| FPV/r100 | Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 | Triglycerides | -13.5 Percent change |
| FPV/r200 | Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 | Total cholesterol | 0.7 Percent change |
| FPV/r200 | Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 | HDL | 0 Percent change |
| FPV/r200 | Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 | Triglycerides | -0.6 Percent change |
Secondary
Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24
Blood samples were drawn at weeks 12 and 24 to determine the plasma levels of APV and RTV. Concentration at the end of the dosing interval at steady state (Ctau) was presented.
Time frame: Weeks 12 and 24
Population: PK Parameter (Ctau) Population - Participants in the ITT-E Population who underwent PK sampling and had evaluable APV or RTV Ctau data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/r100 | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 12 APV Ctau | 1.38 micrograms/mL |
| FPV/r100 | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 24 RTV Ctau | 0.022 micrograms/mL |
| FPV/r100 | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 12 RTV Ctau | 0.026 micrograms/mL |
| FPV/r100 | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 24 APV Ctau | 1.27 micrograms/mL |
| FPV/r200 | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 24 APV Ctau | 1.49 micrograms/mL |
| FPV/r200 | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 12 RTV Ctau | 0.050 micrograms/mL |
| FPV/r200 | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 12 APV Ctau | 1.28 micrograms/mL |
| FPV/r200 | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 24 RTV Ctau | 0.056 micrograms/mL |
| FPV/RTV 700/100 mg BID | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 12 APV Ctau | 1.35 micrograms/mL |
| FPV/RTV 700/100 mg BID | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 24 APV Ctau | 2.38 micrograms/mL |
| FPV/RTV 700/100 mg BID | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 12 RTV Ctau | 0.228 micrograms/mL |
| FPV/RTV 700/100 mg BID | Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 | Week 24 RTV Ctau | 0.203 micrograms/mL |