Infection, Human Immunodeficiency Virus I
Conditions
Keywords
antiretroviral therapy, pediatrics, AGENERASE, amprenavir, fosamprenavir, HIV Infection, ritonavir, protease inhibitor, LEXIVA
Brief summary
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
Detailed description
A 48 Week, Phase II, non-comparative, open-label, multi-cohort, multicenter study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of GW433908/Ritonavir BID when administered to HIV-1 infected PI-Naive and experienced, Pediatric Subjects 2 to 18 years old and of GW433908 BID Administered to PI-Naive Pediatric subjects 2 to \<6 years old
Interventions
Fosamprenavir suspension or tablet bid
DRUGRitonavir
Ritonavir solution bid
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Males or females 2 to 18 years of age Cohorts 1A and 1B, up to one month before 6th birthday at Baseline/Day 1 Cohort 2, up to one month before 12th birthday at Baseline/Day 1 Cohort 3, up to one month before 19th birthday at Baseline/Day 1 * A female is eligible to enter and participate in this study if she is of: 1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial); or, 2. child-bearing potential with a negative serum pregnancy test at screen, a negative urine pregnancy test on Day 1 and who agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the product label and the instructions of a physician). Premenarchial females who develop child-bearing potential while on the study will be expected to follow one of the methods of contraception listed below. Agreement for complete abstinence from intercourse from 2 weeks prior to administration of study drugs, throughout the study and for 2 weeks after discontinuation of all study medications. Should a female subject of childbearing potential decide to become sexually active during the course of the study, she must be counseled and be willing to use one of the contraception methods listed below: Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide) Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion) Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year. Hormonal contraception is not recommended, due to decreased efficacy of contraception as well as increased risk of hepatic transaminase elevation (see Section 8.2). All subjects of childbearing potential or developing child-bearing potential while participating in this study should be counseled on the practice of safe/safer sex. * Parent or legal guardian (and subject whenever possible) has the ability to understand and provide written informed consent for the subject to participate in the trial. Verbal witnessed assent must be obtained from the subject whenever possible. * Screening plasma HIV-1 RNA \>=400copies/mL. * Subjects must meet one of the following criterion: Antiretroviral therapy (ART)-naïve or PI-naïve subjects (defined as having received less than one week of any PI and any length of therapy with Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and/or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)). PI-experienced subjects (defined as having received greater than one week prior PI therapy with no more than three PIs). Prior RTV boosted PI therapy will be considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral age
Exclusion criteria
* Prior history of having received APV or FPV for \>7 days. * NNRTI use within 14 days prior to study drug administration or anticipated need for concurrent NNRTI therapy during the treatment period of the study. * Subjects who, in the investigator's opinion, are not able to comply with the requirements of the study. * Subject is in the initial acute phase of a Centers for Disease Control and Prevention (CDC) Clinical Category C event or infection (per 1994 classification) at Baseline. Subject may be enrolled provided they are receiving treatment for the infection, such treatment not being contraindicated with FPV, and the subjects are clinically improving at the Baseline visit. * Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication. * Pregnant or lactating females. * Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia, a history of insulin resistance, diabetes, cardiac dysfunction, hepatitis or clinically relevant pancreatitis) which, in the opinion of the investigator, might compromise the safety of the subject. * Grade 3 or 4 transaminase levels (ALT and/or AST) within 28 days prior to study drug administration and/or clinically relevant episodes of hepatitis within the previous 6 months. * Any acute laboratory abnormality at screen which, in the opinion of the investigator, should preclude the subject's participation in the study of an investigational compound. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the screening window. Any verified Grade 4 laboratory abnormality at screen would exclude a subject from study participation. * Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or an anticipated need for such treatment within the study period. * Treatment with immunomodulating agents (e.g., systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (e.g., hydroxyurea or foscarnet) within 28 days of study drug administration. * Treatment with any of the following medications within 28 days prior to receiving study medication or the anticipated need during the study: Drugs whose plasma concentration may be increased to unsafe levels when co-administered with FPV including: Amiodarone, astemizole, bepridil, cisapride, dihydroergotamine, ergonovine, ergotamine, flecainide, halofantrine, lidocaine, lovastatin, methylergonovine, midazolam, pimozide, propafenone, quinidine, simvastatin, terfenadine, and triazolam Drugs with the potential to significantly decrease plasma APV concentrations including: Carbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort. * Treatment with other investigational drugs/therapies (note: treatments available through a Treatment Investigational New Drug \[IND\] or other expanded-access mechanism will be evaluated on a case-by-case basis in consultation with the sponsor) within 28 days prior to study drug administration or during the treatment period of the study. * History of drug or other allergy which, in the opinion of the investigator, contraindicates participation in the trial or known hypersensitivity to any study medications (e.g., documented hypersensitivity to a nucleoside analogue). * Substantial non-adherence based on history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Amprenavir (APV) AUC (0-tau[τ]) | Week 48 | Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hr, hour; µg, micrograms; mL, milliliter. |
| Plasma APV Cmax | Week 48 | The maximum concentration at steady state (Cmax) was measured. |
| Plasma APV Cτ | Week 48 | The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured. |
| Plasma APV CL/F Following Dosing Expressed in mg/kg | Week 48 | Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations. |
| Plasma APV CL/F Following Dosing Expressed in mg | Week 48 | Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). |
| Plasma APV Tmax | Week 48 | The time to reach the maximum concentration (Cmax) at steady state is defined as tmax. |
| Plasma APV t1/2 | Week 48 | The apparent terminal phase half-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression. |
| Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE) | Week 48 | An AE is 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. |
| Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | Baseline (Day 1) and Week 48 | Blood samples of all participants were collected under fasting conditions for the evaluation of triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose was calculated as the value at Week 48 minus the value at Baseline. |
| Change From Baseline in Serum Lipase at Week 48 | Baseline (Day 1) and Week 48 | Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at Week 48 minus the value at Baseline. |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48 | Baseline (Day 1) and Week 48 | Blood samples of the participants were collected for the evaluation of AST and ALT. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in AST and ALT was calculated as the value at Week 48 minus the value at Baseline. |
| Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Baseline (Day 1) until Week 48 | A toxicity was considered TE if it was \> than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Leucopenia is the decrease in the number of leucocytes (white blood cells \[WBCs\]); neutropenia is the decrease in the number of neutrophils (type of WBCs). Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs: Grade 3 is severe; Grade 4 is potentially life-threatening. ULN, upper limit of normal; LDL, low-density lipoprotein; PC, platelet count. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma FPV t1/2 | Week 48 | The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated. |
| Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | Week 48 | Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced.Virologic success was defined as plasma HIV-1 RNA \<400 copies/mL. Virologic failure: (1) HIV-1 RNA \>=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 \>=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons, (c) missing data during window but still on study. |
| Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | Baseline and Weeks 2, 12, 24, and 48 | Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation = Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders. |
| Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | Baseline and Weeks 2, 12, 24, and 48 | Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. |
| Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | Baseline and Weeks 2, 12, 24, and 48 | Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. Change from Baseline at Weeks 2, 12, 24, and 48 was calculated as value at Week 2, 12, 24, and 48 minus the value at Baseline. |
| Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | Baseline and Weeks 2, 12, 24, and 48 | Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. |
| Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | Baseline and Weeks 2, 12, 24, and 48 | Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. 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. |
| Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | Baseline and Weeks 2, 12, 24, and 48 | Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline. |
| Plasma Ritonavir (RTV) AUC (0-τ) | Week 48 | Plasma samples were assayed for RTV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. |
| Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | Baseline and Week 2, 12, 24, 48 | Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline. |
| Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Week 48 | A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience. |
| Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | After Week 48 through Week 240 | A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience. |
| Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Baseline through 48 Weeks | A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure. |
| Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Week 60 through Week 240 | A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure. |
| Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Weeks 2, 12, 24, and 48 | The PACTG Adherence Questionnaire records individual study drugs, the expected number of doses/24 hour period, and the number of doses missed in the 3 days prior to the study visit. Responses were summarized by age cohort, study drug, treatment regimen, and visit for exploratory analysis only. |
| Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events | Week 48 | No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes. |
| Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | Baseline and Weeks 2, 12, 24, and 48 | Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. |
| Plasma RTV Cmax | Week 48 | The maximum concentration at steady state (Cmax) was measured. |
| Plasma RTV Cτ | Week 48 | The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured. |
| Plasma RTV CL/F Following Dosing Expressed in mg/kg | Week 48 | Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: RTV Dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations. |
| Plasma RTV CL/F Following Dosing Expressed in mg | Week 48 | Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). |
| Plasma RTV Tmax | Week 48 | The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax). |
| Plasma RTV t1/2 | Week 48 | alf-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression. |
| Plasma FPV AUC (0-τ) | Week 48 | The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated. |
| Plasma FPV Cmax and Cτ | Week 48 | The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated. |
| Plasma FPV CL/F Following Dosing Expressed in mg/kg | Week 48 | The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated. |
| Plasma FPV CL/F Following Dosing Expressed in mg | Week 48 | The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated. |
| Plasma FPV Tmax | Week 48 | The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated. |
Countries
Belgium, Canada, Romania, Russia, South Africa, Spain, United States
Participant flow
Recruitment details
A total of 110 participants (par.) were enrolled in the study; however, 1 par. withdrew from the study prior to the first dose of study drug and was not included in the Intent-to-Treat Exposed or Safety Populations. Therefore, 109 par. received \>=1 dose of study drug and are thus categorized as starting the study in the Participant Flow module.
Participants by arm
| Arm | Count |
|---|---|
| FPV Treatment Group Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to \<6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs). | 20 |
| FPV/RTV Treatment Group HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-\<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent. | 89 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Insufficient Viral Load Response | 5 | 5 |
| Overall Study | Necessity to Use Prohibited Drug | 1 | 0 |
| Overall Study | Non-Compliance | 0 | 4 |
| Overall Study | Participant Incarcerated | 0 | 1 |
| Overall Study | Participant Management Criteria Met | 0 | 1 |
| Overall Study | Participant (Par) Didn't Take Medication | 1 | 0 |
| Overall Study | Participant Refused Study Medication | 0 | 2 |
| Overall Study | Poor Medical Compliance/Adherence Issues | 0 | 3 |
| Overall Study | Principal Investigator Decision | 0 | 10 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Reason Not Provided | 0 | 1 |
| Overall Study | Start of Disallowed Medication | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | FPV Treatment Group | FPV/RTV Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 2.9 Years STANDARD_DEVIATION 1.07 | 10.0 Years STANDARD_DEVIATION 4.49 | 8.7 Years STANDARD_DEVIATION 4.93 |
| Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification <13 years (yrs); mildly symptomatic (S) | 18 participants | 26 participants | 44 participants |
| Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification >=13 yrs; AIDS | 0 participants | 5 participants | 5 participants |
| Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification >=13 yrs; asymptomatic/lymphadenopathy/acute HIV | 0 participants | 12 participants | 12 participants |
| Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification >=13 yrs; asymptomatic, not AIDS | 0 participants | 14 participants | 14 participants |
| Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification <13 yrs; moderately S | 1 participants | 15 participants | 16 participants |
| Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification <13 yrs; non-S | 1 participants | 5 participants | 6 participants |
| Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification >=13 yrs; not reported | 0 participants | 2 participants | 2 participants |
| Par with the Indicated 1993 Center for Disease Control and Prevention (CDC) Baseline Classification <13 yrs; severely S | 0 participants | 10 participants | 10 participants |
| Race/Ethnicity, Customized Arabic/North African | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black | 0 participants | 43 participants | 43 participants |
| Race/Ethnicity, Customized Race Not Specified | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized South Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White/Caucasian | 19 participants | 41 participants | 60 participants |
| Sex: Female, Male Female | 15 Participants | 43 Participants | 58 Participants |
| Sex: Female, Male Male | 5 Participants | 46 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 20 | 74 / 89 |
| serious Total, serious adverse events | 5 / 20 | 13 / 89 |
Outcome results
Primary
Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48
Blood samples of the participants were collected for the evaluation of AST and ALT. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in AST and ALT was calculated as the value at Week 48 minus the value at Baseline.
Time frame: Baseline (Day 1) and Week 48
Population: Safety Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Treatment Group | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48 | ALT | -3 International units per liter (IU/L) |
| FPV Treatment Group | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48 | AST | -6 International units per liter (IU/L) |
| FPV/RTV Treatment Group | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48 | AST | -9 International units per liter (IU/L) |
| FPV/RTV Treatment Group | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48 | ALT | -7 International units per liter (IU/L) |
Primary
Change From Baseline in Serum Lipase at Week 48
Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at Week 48 minus the value at Baseline.
Time frame: Baseline (Day 1) and Week 48
Population: Safety Population. Only those participants contributing data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FPV Treatment Group | Change From Baseline in Serum Lipase at Week 48 | -2.0 Units per liter (U/L) |
| FPV/RTV Treatment Group | Change From Baseline in Serum Lipase at Week 48 | -1.0 Units per liter (U/L) |
Primary
Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48
Blood samples of all participants were collected under fasting conditions for the evaluation of triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose was calculated as the value at Week 48 minus the value at Baseline.
Time frame: Baseline (Day 1) and Week 48
Population: Safety Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | Total cholesterol; n=17, 65 | 1.1 Millimoles per liter (mmol/L) |
| FPV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | LDL cholesterol; n=17, 64 | 0.6 Millimoles per liter (mmol/L) |
| FPV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | HDL cholesterol; n=17, 65 | 0.4 Millimoles per liter (mmol/L) |
| FPV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | Glucose; n=18, 69 | 0.0 Millimoles per liter (mmol/L) |
| FPV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | Triglycerides; n=17, 65 | 0.1 Millimoles per liter (mmol/L) |
| FPV/RTV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | Glucose; n=18, 69 | 0.1 Millimoles per liter (mmol/L) |
| FPV/RTV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | Triglycerides; n=17, 65 | 0.2 Millimoles per liter (mmol/L) |
| FPV/RTV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | Total cholesterol; n=17, 65 | 0.9 Millimoles per liter (mmol/L) |
| FPV/RTV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | HDL cholesterol; n=17, 65 | 0.3 Millimoles per liter (mmol/L) |
| FPV/RTV Treatment Group | Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48 | LDL cholesterol; n=17, 64 | 0.5 Millimoles per liter (mmol/L) |
Primary
Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)
An AE is 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: Week 48
Population: Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FPV Treatment Group | Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE) | 0 participants |
| FPV/RTV Treatment Group | Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE) | 4 participants |
Primary
Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities
A toxicity was considered TE if it was \> than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Leucopenia is the decrease in the number of leucocytes (white blood cells \[WBCs\]); neutropenia is the decrease in the number of neutrophils (type of WBCs). Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs: Grade 3 is severe; Grade 4 is potentially life-threatening. ULN, upper limit of normal; LDL, low-density lipoprotein; PC, platelet count.
Time frame: Baseline (Day 1) until Week 48
Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | AST inc. (>5.0x ULN); n=20, 87 | 2 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Hyperglycemia (>13.88 mmol/L); n=16, 58 | 0 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Lipase inc. (>3.0x ULN); n=19, 85 | 0 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | ALT increased (inc.) (>5.0x ULN); n=20, 87 | 2 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Leucopenia (<1.500 x 10^9/L); n=20, 84 | 0 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Hypoglycemia (<2.22 mmol/L); n=16, 58 | 0 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Neutropenia (<0.750 x 10^9/L); n=20, 84 | 8 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Cholesterol (Chol.) inc. (>7.77 mmol/L); n=16, 43 | 0 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Hemoglobin > anemia (<1.16 mmol/L); n=20, 85 | 0 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | LDL Chol. inc. (>=4.91 mmol/L); n=16, 43 | 0 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | PC > thrombocytopenia (<50.000 x 10^9/L); n=20, 85 | 0 participants |
| FPV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Triglycerides inc. (>8.48 mmol/L); n=16, 43 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | PC > thrombocytopenia (<50.000 x 10^9/L); n=20, 85 | 1 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | ALT increased (inc.) (>5.0x ULN); n=20, 87 | 2 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | AST inc. (>5.0x ULN); n=20, 87 | 2 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Cholesterol (Chol.) inc. (>7.77 mmol/L); n=16, 43 | 2 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Hyperglycemia (>13.88 mmol/L); n=16, 58 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Hypoglycemia (<2.22 mmol/L); n=16, 58 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | LDL Chol. inc. (>=4.91 mmol/L); n=16, 43 | 4 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Triglycerides inc. (>8.48 mmol/L); n=16, 43 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Lipase inc. (>3.0x ULN); n=19, 85 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Leucopenia (<1.500 x 10^9/L); n=20, 84 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Neutropenia (<0.750 x 10^9/L); n=20, 84 | 7 participants |
| FPV/RTV Treatment Group | Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities | Hemoglobin > anemia (<1.16 mmol/L); n=20, 85 | 0 participants |
Primary
Plasma Amprenavir (APV) AUC (0-tau[τ])
Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hr, hour; µg, micrograms; mL, milliliter.
Time frame: Week 48
Population: Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | NA hr*µg/mL |
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 2 to <6 yrs, 30 mg/kg BID; n=9, 0 | 22.3 hr*µg/mL |
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 2 to <6 yrs, 40 mg/kg BID; n=7, 0 | 24.1 hr*µg/mL |
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 2 to <6 yrs, 23/3 mg/kg BID; n=0, 14 | NA hr*µg/mL |
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 9 | NA hr*µg/mL |
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 12 | NA hr*µg/mL |
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | NA hr*µg/mL |
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | NA hr*µg/mL |
| FPV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 12 to 18 yrs, 18/3 mg BID; n=0, 3 | NA hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | 21.8 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | 35.3 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 12 | 48.4 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 2 to <6 yrs, 30 mg/kg BID; n=9, 0 | NA hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 2 to <6 yrs, 23/3 mg/kg BID; n=0, 14 | 55.3 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 2 to <6 yrs, 40 mg/kg BID; n=7, 0 | NA hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | 37.6 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 12 to 18 yrs, 18/3 mg BID; n=0, 3 | 41.7 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 9 | 32.3 hr*µg/mL |
Primary
Plasma APV CL/F Following Dosing Expressed in mg
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 12 to 18 yrs, 18/3 mg BID; n=0, 3 | NA Milliliters per minute (mL/min) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 2 to <6yrs, 30 mg/kg BID; n=9, 0 | 269 Milliliters per minute (mL/min) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 2 to <6yrs, 40 mg/kg BID; n=7, 0 | 330 Milliliters per minute (mL/min) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 2 to <6yrs, 23/3 mg/kg BID; n=0, 14 | NA Milliliters per minute (mL/min) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 9 | NA Milliliters per minute (mL/min) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 12 | NA Milliliters per minute (mL/min) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | NA Milliliters per minute (mL/min) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | NA Milliliters per minute (mL/min) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | NA Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | 392 Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 12 | 149 Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 2 to <6yrs, 30 mg/kg BID; n=9, 0 | NA Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 12 to 18 yrs, 18/3 mg BID; n=0, 3 | 198 Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 2 to <6yrs, 40 mg/kg BID; n=7, 0 | NA Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | 266 Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 2 to <6yrs, 23/3 mg/kg BID; n=0, 14 | 91 Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | 284 Milliliters per minute (mL/min) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 9 | 195 Milliliters per minute (mL/min) |
Primary
Plasma APV CL/F Following Dosing Expressed in mg/kg
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 2 to <6yrs, 40 mg/kg BID; n=7, 0 | 23.4 Milliliters/minute/kilogram (mL/min/kg) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 12 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 2 to <6yrs, 30 mg/kg BID; n=9, 0 | 19.3 Milliliters/minute/kilogram (mL/min/kg) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 2 to <6yrs, 23/3 mg/kg BID; n=0, 14 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 12 to 18 yrs, 18/3 mg BID; n=0, 3 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 9 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | 5.33 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 2 to <6yrs, 30 mg/kg BID; n=9, 0 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 2 to <6yrs, 40 mg/kg BID; n=7, 0 | NA Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 2 to <6yrs, 23/3 mg/kg BID; n=0, 14 | 6.06 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 9 | 6.48 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 12 | 5.27 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | 10.1 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 12 to 18 yrs, 18/3 mg BID; n=0, 3 | 6.00 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV Treatment Group | Plasma APV CL/F Following Dosing Expressed in mg/kg | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | 5.94 Milliliters/minute/kilogram (mL/min/kg) |
Primary
Plasma APV Cmax
The maximum concentration at steady state (Cmax) was measured.
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV Treatment Group | Plasma APV Cmax | 2 to <6 yrs, 30 mg/kg BID; n=9, 0 | 7.15 Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cmax | 6 to <12.yrs, 18/3 mg/kg BID; n=0, 12 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cmax | 2 to <6 yrs, 23/3 mg/kg BID; n=0, 14 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cmax | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cmax | 2 to <6 yrs, 40 mg/kg BID; n=7, 0 | 6.52 Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cmax | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cmax | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 10 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cmax | 12 to 18 yrs, 18/3 mg/kg BID; n=0, 4 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cmax | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | NA Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 12 to 18 yrs, 18/3 mg/kg BID; n=0, 4 | 4.91 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | 4.93 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 2 to <6 yrs, 30 mg/kg BID; n=9, 0 | NA Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 2 to <6 yrs, 40 mg/kg BID; n=7, 0 | NA Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 2 to <6 yrs, 23/3 mg/kg BID; n=0, 14 | 8.66 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 10 | 4.34 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 6 to <12.yrs, 18/3 mg/kg BID; n=0, 12 | 6.40 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | 5.85 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cmax | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | 3.92 Micrograms per milliliter (µg/mL) |
Primary
Plasma APV Cτ
The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV Treatment Group | Plasma APV Cτ | 2 to <6 yrs, 40 mg/kg BID; n=10, 0 | 0.70 Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cτ | 6 to <12 yrs, 700/100 mg BID; n=0, 7 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cτ | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 13 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cτ | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 6 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cτ | 2 to <6 yrs, 23/3 mg/kg BID; n=0, 16 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cτ | 12 to 18 yrs, 18/3 mg/kg BID; n=0, 10 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cτ | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 23 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cτ | 12 to 18 yrs, 700/100 mg BID; n=0, 40 | NA Micrograms per milliliter (µg/mL) |
| FPV Treatment Group | Plasma APV Cτ | 2 to <6 yrs, 30 mg/kg BID; n=19, 0 | 0.55 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 12 to 18 yrs, 700/100 mg BID; n=0, 40 | 2.01 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 2 to <6 yrs, 30 mg/kg BID; n=19, 0 | NA Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 2 to <6 yrs, 40 mg/kg BID; n=10, 0 | NA Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 2 to <6 yrs, 23/3 mg/kg BID; n=0, 16 | 3.39 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 13 | 2.24 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 23 | 2.42 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 6 to <12 yrs, 700/100 mg BID; n=0, 7 | 1.81 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 6 | 1.45 Micrograms per milliliter (µg/mL) |
| FPV/RTV Treatment Group | Plasma APV Cτ | 12 to 18 yrs, 18/3 mg/kg BID; n=0, 10 | 1.80 Micrograms per milliliter (µg/mL) |
Primary
Plasma APV t1/2
The apparent terminal phase half-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV Treatment Group | Plasma APV t1/2 | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | NA hours |
| FPV Treatment Group | Plasma APV t1/2 | 2 to <6yrs, 30 mg/kg BID; n=9, 0 | 3.03 hours |
| FPV Treatment Group | Plasma APV t1/2 | 2 to <6yrs, 40 mg/kg BID; n=5, 0 | 3.18 hours |
| FPV Treatment Group | Plasma APV t1/2 | 2 to <6yrs, 23/3 mg/kg BID; n=0, 14 | NA hours |
| FPV Treatment Group | Plasma APV t1/2 | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 7 | NA hours |
| FPV Treatment Group | Plasma APV t1/2 | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 10 | NA hours |
| FPV Treatment Group | Plasma APV t1/2 | 6 to <12 yrs, 700/100 mg BID; n=0, 2 | NA hours |
| FPV Treatment Group | Plasma APV t1/2 | 12 to 18 yrs, 18/3 mg BID; n=0, 4 | NA hours |
| FPV Treatment Group | Plasma APV t1/2 | 12 to 18 yrs, 700/100 mg BID; n=0, 11 | NA hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 12 to 18 yrs, 700/100 mg BID; n=0, 11 | 7.64 hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 10 | 8.41 hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 2 to <6yrs, 30 mg/kg BID; n=9, 0 | NA hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 12 to 18 yrs, 18/3 mg BID; n=0, 4 | 8.76 hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 2 to <6yrs, 40 mg/kg BID; n=5, 0 | NA hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 6 to <12 yrs, 700/100 mg BID; n=0, 2 | 7.43 hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 2 to <6yrs, 23/3 mg/kg BID; n=0, 14 | 5.21 hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | 6.12 hours |
| FPV/RTV Treatment Group | Plasma APV t1/2 | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 7 | 10.5 hours |
Primary
Plasma APV Tmax
The time to reach the maximum concentration (Cmax) at steady state is defined as tmax.
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Treatment Group | Plasma APV Tmax | 2 to <6yrs, 23/3 mg/kg BID; n=0, 14 | NA hours |
| FPV Treatment Group | Plasma APV Tmax | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | NA hours |
| FPV Treatment Group | Plasma APV Tmax | 2 to <6yrs, 40 mg/kg BID; n=7, 0 | 1.00 hours |
| FPV Treatment Group | Plasma APV Tmax | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | NA hours |
| FPV Treatment Group | Plasma APV Tmax | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 10 | NA hours |
| FPV Treatment Group | Plasma APV Tmax | 12 to 18 yrs, 18/3 mg BID; n=0, 3 | NA hours |
| FPV Treatment Group | Plasma APV Tmax | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 12 | NA hours |
| FPV Treatment Group | Plasma APV Tmax | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | NA hours |
| FPV Treatment Group | Plasma APV Tmax | 2 to <6yrs, 30 mg/kg BID; n=9, 0 | 1.17 hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 12 to 18 yrs, 700/100 mg BID; n=0, 13 | 2.00 hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 6 to <12 yrs, 15/3 mg/kg BID; n=0, 10 | 2.00 hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 2 to <6yrs, 30 mg/kg BID; n=9, 0 | NA hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 2 to <6yrs, 40 mg/kg BID; n=7, 0 | NA hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 2 to <6yrs, 23/3 mg/kg BID; n=0, 14 | 1.25 hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 6 to <12 yrs, 18/3 mg/kg BID; n=0, 12 | 1.96 hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 6 to <12 yrs, 700/100 mg BID; n=0, 3 | 3.92 hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 12 to 18 yrs, 15/3 mg/kg BID; n=0, 4 | 1.00 hours |
| FPV/RTV Treatment Group | Plasma APV Tmax | 12 to 18 yrs, 18/3 mg BID; n=0, 3 | 1.50 hours |
Secondary
Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48
Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.
Time frame: Baseline and Weeks 2, 12, 24, and 48
Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-exp, Week 2; n=0, 32 | NA cells/cu mm |
| FPV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-naïve, Week 2; n=13, 41 | 20 cells/cu mm |
| FPV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-exp, Week 12; n=0, 31 | NA cells/cu mm |
| FPV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-naïve, Week 24; n=18, 44 | 350 cells/cu mm |
| FPV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-exp, Week 24; n=0, 34 | NA cells/cu mm |
| FPV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-naïve, Week 12; n=19, 46 | 170 cells/cu mm |
| FPV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-exp, Week 48; n=0, 29 | NA cells/cu mm |
| FPV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-naïve, Week 48; n=17, 42 | 340 cells/cu mm |
| FPV/RTV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-exp, Week 48; n=0, 29 | 180 cells/cu mm |
| FPV/RTV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-naïve, Week 48; n=17, 42 | 217 cells/cu mm |
| FPV/RTV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-naïve, Week 12; n=19, 46 | 180 cells/cu mm |
| FPV/RTV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-naïve, Week 24; n=18, 44 | 184 cells/cu mm |
| FPV/RTV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-exp, Week 2; n=0, 32 | 90 cells/cu mm |
| FPV/RTV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-exp, Week 12; n=0, 31 | 200 cells/cu mm |
| FPV/RTV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-exp, Week 24; n=0, 34 | 150 cells/cu mm |
| FPV/RTV Treatment Group | Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48 | PI-naïve, Week 2; n=13, 41 | 60 cells/cu mm |
Secondary
Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48
Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.
Time frame: Baseline and Week 2, 12, 24, 48
Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-exp, Week 2; n=0, 32 | NA Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-exp, Week 48; n=0, 29 | NA Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-naïve, Week 2; n=13, 41 | 3 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-naïve, Week 12; n=19, 46 | 6 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-naïve, Week 24; n=18, 44 | 7 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-naïve, Week 48; n=17, 42 | 8 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-exp, Week 12; n=0, 31 | NA Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-exp, Week 24; n=0, 34 | NA Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-exp, Week 48; n=0, 29 | 6 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-naïve, Week 48; n=17, 42 | 10 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-exp, Week 2; n=0, 32 | 2 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-naïve, Week 2; n=13, 41 | 1 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-exp, Week 24; n=0, 34 | 5 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-naïve, Week 12; n=19, 46 | 5 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-exp, Week 12; n=0, 31 | 3 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48 | PI-naïve, Week 24; n=18, 44 | 8 Percentage of TLs that are CD4+ cells |
Secondary
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48
Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. 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 2, 12, 24, and 48
Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Baseline; n= 19, 49 | 810 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 387.42 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Baseline; n= 0, 40 | NA Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 0 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Week 2; n= 0, 32 | NA Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 0 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Week 12; n= 19, 46 | 1040 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 606.25 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Week 12; n= 0, 31 | NA Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 0 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Week 2; n= 13, 41 | 820 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 370.81 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Week 24; n= 0, 34 | NA Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 0 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Week 24; n= 18, 44 | 1260 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 482.92 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Week 48; n= 0, 29 | NA Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 0 |
| FPV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Week 48; n= 18, 42 | 1080 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 611.28 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Week 48; n= 0, 29 | 540 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 297.8 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Baseline; n= 0, 40 | 440 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 562 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Baseline; n= 19, 49 | 370 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 399.39 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Week 2; n= 13, 41 | 450 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 575.73 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Week 12; n= 19, 46 | 581 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 555.52 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Week 48; n= 18, 42 | 670 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 568.2 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Week 2; n= 0, 32 | 605 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 444.63 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Week 12; n= 0, 31 | 720 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 379.84 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-exp, Week 24; n= 0, 34 | 620 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 420.62 |
| FPV/RTV Treatment Group | Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48 | PI-naïve, Week 24; n= 18, 44 | 609 Cells per cubic millimeter (cells/cu mm) | Inter-Quartile Range 509.24 |
Secondary
Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events
No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.
Time frame: Week 48
Population: PK Population
Secondary
Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. Change from Baseline at Weeks 2, 12, 24, and 48 was calculated as value at Week 2, 12, 24, and 48 minus the value at Baseline.
Time frame: Baseline and Weeks 2, 12, 24, and 48
Population: ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 12; n=19, 46 | -3.04 log10/copies |
| FPV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 24; n=18, 44 | -3.16 log10/copies |
| FPV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 2; n=0, 32 | NA log10/copies |
| FPV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 24; n=0, 35 | NA log10/copies |
| FPV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 48; n=18, 44 | -3.02 log10/copies |
| FPV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 12; n=0, 33 | NA log10/copies |
| FPV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 48; n=0, 33 | NA log10/copies |
| FPV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 2; n=14, 39 | -1.91 log10/copies |
| FPV/RTV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 48; n=0, 33 | -2.14 log10/copies |
| FPV/RTV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 2; n=14, 39 | -1.84 log10/copies |
| FPV/RTV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 2; n=0, 32 | -1.58 log10/copies |
| FPV/RTV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 24; n=0, 35 | -2.28 log10/copies |
| FPV/RTV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 12; n=19, 46 | -2.77 log10/copies |
| FPV/RTV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 12; n=0, 33 | -2.23 log10/copies |
| FPV/RTV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 24; n=18, 44 | -2.87 log10/copies |
| FPV/RTV Treatment Group | Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 48; n=18, 44 | -2.83 log10/copies |
Secondary
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.
Time frame: Baseline and Weeks 2, 12, 24, and 48
Population: ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Baseline; n=0, 39 | NA log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 12; n=19, 46 | 2.03 log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Baseline; n=20, 49 | 5.13 log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 12; n=0, 34 | NA log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 2; n=14, 39 | 3.27 log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 24; n=18, 44 | 1.85 log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 48; n=0, 33 | NA log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 24; n=0, 35 | NA log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 2; n=0, 33 | NA log10 copies/mL |
| FPV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 48; n=18, 44 | 1.85 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 48; n=0, 33 | 1.69 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 48; n=18, 44 | 1.69 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Baseline; n=20, 49 | 4.72 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Baseline; n=0, 39 | 4.53 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 2; n=14, 39 | 3.06 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 2; n=0, 33 | 3.04 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 12; n=19, 46 | 1.94 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 12; n=0, 34 | 2.20 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 24; n=18, 44 | 1.69 log10 copies/mL |
| FPV/RTV Treatment Group | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 24; n=0, 35 | 1.80 log10 copies/mL |
Secondary
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.
Time frame: After Week 48 through Week 240
Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I47IV | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I84I/V | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184V | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV PI Mutations | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10F | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33F | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V32I | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I62I/V | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation T215S/Y | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I85V | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NRTI Mutation | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Major HIV NNRTI Mutation | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation K103N | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV NNRTI Mutation | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M41L | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation V179D/E | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV Major PI Mutations | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation T74P | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46L | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184I | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V32I | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184I | 1 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation T74P | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I84I/V | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation V179D/E | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Major HIV NNRTI Mutation | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NRTI Mutation | 1 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV PI Mutations | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M41L | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10F | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184V | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation K103N | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33F | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46L | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I47IV | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I62I/V | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV NNRTI Mutation | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV Major PI Mutations | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I85V | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation T215S/Y | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I85V | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV PI Mutations | 2 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NRTI Mutation | 2 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M41L | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184I | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184V | 2 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation T215S/Y | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Major HIV NNRTI Mutation | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation K103N | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV NNRTI Mutation | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation V179D/E | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V32I | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46L | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I47IV | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation T74P | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I84I/V | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10F | 0 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33F | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I62I/V | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV Major PI Mutations | 1 Participants |
Secondary
Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)
A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.
Time frame: Week 60 through Week 240
Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir- boosted Fosamprenavir | NA Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Zidovudine | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Abacavir | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Unboosted Fosamprenavir | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Delaviridine | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Tipranavir | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Nelfinavir | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Efavirenz | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 1 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Didanosine | 0 Participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Nevirapine | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 1 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 1 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 1 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir- boosted Fosamprenavir | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 1 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Nelfinavir | 1 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Tipranavir | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Nevirapine | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Unboosted Fosamprenavir | NA Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Zidovudine | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Abacavir | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Delaviridine | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Efavirenz | 0 Participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Didanosine | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Tipranavir | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 3 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Abacavir | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Didanosine | 3 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 3 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 2 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Zidovudine | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Delaviridine | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Efavirenz | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Nevirapine | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 3 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Unboosted Fosamprenavir | NA Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir- boosted Fosamprenavir | 1 Participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS) | Nelfinavir | 0 Participants |
Secondary
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.
Time frame: Week 48
Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation V179D/E | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I84I/V | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV Major PI Mutations | 2 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46M/I | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation K20K/R | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation F53F/L | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10L/F | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV PI Mutations | 2 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V82F/I | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46M/L | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I85I/V | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I62I/V | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184V | 3 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation Q58Q/E | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation K43K/T | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/L | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I50I/V | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation A71I/V | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NRTI Mutation | 3 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/M | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NNRTI Mutation | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33L/F | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/M/V | 0 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V82A/V | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation F53L | 1 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I62I/V | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation F53F/L | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V82F/I | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10L/F | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I84I/V | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NRTI Mutation | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV PI Mutations | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184V | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation F53L | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NNRTI Mutation | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation V179D/E | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV Major PI Mutations | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I85I/V | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46M/I | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation Q58Q/E | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation K43K/T | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46M/L | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation A71I/V | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I50I/V | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V82A/V | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/L | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33L/F | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/M | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/M/V | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation K20K/R | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NNRTI Mutation | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation V179D/E | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/M | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation F53F/L | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NRTI Mutation | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184V | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV Major PI Mutations | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46M/I | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46M/L | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I50I/V | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/L | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/M/V | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation Q58Q/E | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V82A/V | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V82F/I | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I84I/V | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV PI Mutations | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10L/F | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation K20K/R | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33L/F | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation K43K/T | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation F53L | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I62I/V | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation A71I/V | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I85I/V | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation K20K/R | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/M | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/L | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I85I/V | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I50I/V | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46M/I | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation A71I/V | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV Major PI Mutations | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation F53F/L | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NNRTI Mutation | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184V | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation M46M/L | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation F53L | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NRTI Mutation | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation K43K/T | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation V179D/E | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation I62I/V | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any Minor HIV PI Mutations | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I84I/V | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V82F/I | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33L/F | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10L/F | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation V82A/V | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation I54I/M/V | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV Major PI Mutation Q58Q/E | 0 participants |
Secondary
Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.
Time frame: Baseline through 48 Weeks
Population: VF: par. with failure to achieve plasma HIV-RNA \<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \>=400 copies/mL any time after achieving plasma HIV-RNA \<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 3 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Didanosine | 3 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Unboosted Fosamprenavir | 2 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 3 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 3 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir- boosted Fosamprenavir | NA participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir | 2 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Abacavir | 1 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 2 participants |
| FPV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir- boosted Fosamprenavir | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Abacavir | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Didanosine | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Unboosted Fosamprenavir | NA participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 participants |
| FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Abacavir | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 1 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Unboosted Fosamprenavir | NA participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Didanosine | 0 participants |
| PI Naïve, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir- boosted Fosamprenavir | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 2 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Abacavir | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Unboosted Fosamprenavir | NA participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir- boosted Fosamprenavir | 1 participants |
| PI Experienced, ART Experienced, FPV/RTV Treatment Group | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Didanosine | 1 participants |
Secondary
Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)
Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation = Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.
Time frame: Baseline and Weeks 2, 12, 24, and 48
Population: Intent-to-Treat Exposed (ITT-E) Population. Only those par. contributing data at the indicated time points were analyzed. The number of par. analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1week prior PI therapy with no more than 3 PIs before trial enrollment) par.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Baseline; n=20, 49 | 0 participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Week 12; n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Week 2; n=20, 49 | 3 participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Week 24; n=20, 49 | 13 participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Week 24; n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Baseline; n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Week 48; n=20, 49 | 12 participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Week 12; n=20, 49 | 13 participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Week 48; n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Week 2; n=0, 40 | NA participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Week 48; n=0, 40 | 19 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Baseline; n=20, 49 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Baseline; n=0, 40 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Week 2; n=20, 49 | 9 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Week 2; n=0, 40 | 5 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Week 12; n=20, 49 | 35 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Week 12; n=0, 40 | 19 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Week 24; n=20, 49 | 35 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-exp, Week 24; n=0, 40 | 22 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F) | PI-naïve, Week 48; n=20, 49 | 36 participants |
Secondary
Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48
Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced.Virologic success was defined as plasma HIV-1 RNA \<400 copies/mL. Virologic failure: (1) HIV-1 RNA \>=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 \>=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons, (c) missing data during window but still on study.
Time frame: Week 48
Population: Intent-to-Treat Exposed (ITT-E) Population: par. with documented evidence of receiving \>=1 treatment dose. Only par. contributing data were analyzed. The number of par. analyzed is the sum of the PI-naïve (received \<1week's treatment with a PI) and -experienced (received \>1week prior PI therapy with no more than 3 PIs before trial enrollment) par.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V failure (2); n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, No V data at Week 48 (b); n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V failure (4); n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, No V data at Week 48 (c); n=20, 49 | 0 participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V failure (3); n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, No V data at Week 48 (c); n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, No V data at Week 48 (a); n=20, 49 | 0 participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, virological (V) success; n=20, 49 | 12 participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, V failure (3); n=20, 49 | 1 participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V success; n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, No V data at Week 48 (a); n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, V failure (1); n=20, 49 | 4 participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve;, V failure (4); n=20, 49 | 1 participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V failure (1); n=0, 40 | NA participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, No V data Week 48 (b); n=20, 49 | 0 participants |
| FPV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, V failure (2); n=20, 49 | 2 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, No V data Week 48 (b); n=20, 49 | 1 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V failure (2); n=0, 40 | 7 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, V failure (3); n=20, 49 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V failure (3); n=0, 40 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve;, V failure (4); n=20, 49 | 3 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V failure (4); n=0, 40 | 3 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, No V data at Week 48 (a); n=20, 49 | 1 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, No V data at Week 48 (a); n=0, 40 | 1 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, V failure (2); n=20, 49 | 4 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, No V data at Week 48 (b); n=0, 40 | 0 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, No V data at Week 48 (c); n=20, 49 | 1 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, No V data at Week 48 (c); n=0, 40 | 2 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, virological (V) success; n=20, 49 | 36 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V success; n=0, 40 | 19 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-naïve, V failure (1); n=20, 49 | 3 participants |
| FPV/RTV Treatment Group | Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48 | PI-exp, V failure (1); n=0, 40 | 8 participants |
Secondary
Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire
The PACTG Adherence Questionnaire records individual study drugs, the expected number of doses/24 hour period, and the number of doses missed in the 3 days prior to the study visit. Responses were summarized by age cohort, study drug, treatment regimen, and visit for exploratory analysis only.
Time frame: Weeks 2, 12, 24, and 48
Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 2, Total Population; n= 17, 59 | 15 participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 2, 2 to <6 years (yrs); n= 17, 16 | 15 participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 2, 6 to <12 yrs; n= 0, 25 | NA participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 2, 12 to 18 yrs; n= 0, 18 | NA participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 12, Total Population; n= 16, 55 | 15 participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 12, 2 to <6 yrs; n= 16, 16 | 15 participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 12, 6 to <12 yrs; n= 0, 24 | NA participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 12, 12 to 18 yrs; n= 0, 15 | NA participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 24, Total Population; n= 16, 54 | 16 participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 24, 2 to <6 yrs; n= 16, 14 | 16 participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 24, 6 to <12 yrs; n= 0, 24 | NA participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 24, 12 to 18 yrs; n= 0, 16 | NA participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 48, Total Population; n= 15, 53 | 13 participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 48, 2 to <6 yrs; n= 15, 14 | 13 participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 48, 6 to <12 yrs; n= 0, 23 | NA participants |
| FPV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 48, 12 to 18 yrs; n= 0, 16 | NA participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 48, 12 to 18 yrs; n= 0, 16 | 9 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 2, Total Population; n= 17, 59 | 49 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 24, Total Population; n= 16, 54 | 43 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 2, 2 to <6 years (yrs); n= 17, 16 | 15 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 48, Total Population; n= 15, 53 | 42 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 2, 6 to <12 yrs; n= 0, 25 | 22 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 24, 2 to <6 yrs; n= 16, 14 | 11 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 2, 12 to 18 yrs; n= 0, 18 | 12 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 48, 6 to <12 yrs; n= 0, 23 | 20 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 12, Total Population; n= 16, 55 | 45 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 24, 6 to <12 yrs; n= 0, 24 | 23 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 12, 2 to <6 yrs; n= 16, 16 | 14 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 48, 2 to <6 yrs; n= 15, 14 | 13 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 12, 6 to <12 yrs; n= 0, 24 | 20 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 24, 12 to 18 yrs; n= 0, 16 | 9 participants |
| FPV/RTV Treatment Group | Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire | Week 12, 12 to 18 yrs; n= 0, 15 | 11 participants |
Secondary
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.
Time frame: Baseline and Weeks 2, 12, 24, and 48
Population: ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 12; n=0, 33 | NA participants |
| FPV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 12; n=19, 46 | 19 participants |
| FPV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 24; n=0, 35 | NA participants |
| FPV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 24; n=18, 44 | 18 participants |
| FPV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 48; n=18, 44 | 17 participants |
| FPV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 2; n=0, 32 | NA participants |
| FPV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 48; n=0, 33 | NA participants |
| FPV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 2; n=14, 39 | 13 participants |
| FPV/RTV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 48; n=0, 33 | 24 participants |
| FPV/RTV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 12; n=0, 33 | 26 participants |
| FPV/RTV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 24; n=18, 44 | 41 participants |
| FPV/RTV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 2; n=14, 39 | 35 participants |
| FPV/RTV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 2; n=0, 32 | 22 participants |
| FPV/RTV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 12; n=19, 46 | 41 participants |
| FPV/RTV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-exp, Week 24; n=0, 35 | 29 participants |
| FPV/RTV Treatment Group | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis) | PI-naïve, Week 48; n=18, 44 | 40 participants |
Secondary
Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48
Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data.
Time frame: Baseline and Weeks 2, 12, 24, and 48
Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received \<1 week's treatment with a PI) and -experienced (received \>1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Week 12; n=19, 46 | 27 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Week 2; n=0, 32 | NA Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Baseline; n=19, 49 | 19 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Week 2; n=13, 41 | 24 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Week 24; n=18, 44 | 31 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Week 48; n=18, 42 | 32 Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Baseline; n=0, 40 | NA Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Week 12; n=0, 31 | NA Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Week 24; n=0, 34 | NA Percentage of TLs that are CD4+ cells |
| FPV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Week 48; n=0, 29 | NA Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Week 24; n=0, 34 | 23 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Week 48; n=18, 42 | 29 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Week 12; n=0, 31 | 23 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Week 48; n=0, 29 | 24 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Baseline; n=19, 49 | 21 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Baseline; n=0, 40 | 24 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Week 2; n=13, 41 | 23 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Week 12; n=19, 46 | 25 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-exp, Week 2; n=0, 32 | 22 Percentage of TLs that are CD4+ cells |
| FPV/RTV Treatment Group | Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48 | PI-naïve, Week 24; n=18, 44 | 28 Percentage of TLs that are CD4+ cells |
Secondary
Plasma FPV AUC (0-τ)
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time frame: Week 48
Population: PK Population
Secondary
Plasma FPV CL/F Following Dosing Expressed in mg
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time frame: Week 48
Population: PK Population
Secondary
Plasma FPV CL/F Following Dosing Expressed in mg/kg
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time frame: Week 48
Population: PK Population
Secondary
Plasma FPV Cmax and Cτ
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time frame: Week 48
Population: PK Population
Secondary
Plasma FPV t1/2
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time frame: Week 48
Population: PK Population
Secondary
Plasma FPV Tmax
The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.
Time frame: Week 48
Population: PK Population
Secondary
Plasma Ritonavir (RTV) AUC (0-τ)
Plasma samples were assayed for RTV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\[0-τ\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.
Time frame: Week 48
Population: PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV Treatment Group | Plasma Ritonavir (RTV) AUC (0-τ) | 2 to <6 yrs, 3 mg/kg BID; n=0, 10 | 3.98 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Ritonavir (RTV) AUC (0-τ) | 6 to <12 yrs, 3 mg/kg BID; n=0, 12 | 7.13 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Ritonavir (RTV) AUC (0-τ) | 6 to <12 yrs, 100 mg BID; n=0, 6 | 6.46 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Ritonavir (RTV) AUC (0-τ) | 12 to 18 yrs, 3 mg/kg BID; n=0, 1 | 5.74 hr*µg/mL |
| FPV/RTV Treatment Group | Plasma Ritonavir (RTV) AUC (0-τ) | 12 to 18 yrs, 100 mg BID; n=0, 15 | 6.13 hr*µg/mL |
Secondary
Plasma RTV CL/F Following Dosing Expressed in mg
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ).
Time frame: Week 48
Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg | 2 to <6yrs, 3 mg/kg BID; n=0, 10 | 195 mL/min |
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg | 6 to <12 yrs, 3 mg/kg BID; n=0, 12 | 190 mL/min |
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg | 6 to <12 yrs, 100 mg/kg BID; n=0, 6 | 258 mL/min |
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg | 12 to 18 yrs, 3 mg/kg BID; n=0, 1 | 279 mL/min |
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg | 12 to 18 yrs, 100 mg BID; n=0, 15 | 272 mL/min |
Secondary
Plasma RTV CL/F Following Dosing Expressed in mg/kg
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: RTV Dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.
Time frame: Week 48
Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg/kg | 6 to <12 yrs, 100 mg/kg BID; n=0, 12 | 5.94 mL/min/kg |
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg/kg | 2 to <6yrs, 3 mg/kg BID; n=0, 10 | 12.9 mL/min/kg |
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg/kg | 6 to <12 yrs, 3 mg/kg BID; n=0, 12 | 6.81 mL/min/kg |
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg/kg | 12 to 18 yrs, 3 mg/kg BID; n=0, 1 | 8.61 mL/min/kg |
| FPV/RTV Treatment Group | Plasma RTV CL/F Following Dosing Expressed in mg/kg | 12 to 18 yrs, 100 mg BID; n=0, 15 | 5.59 mL/min/kg |
Secondary
Plasma RTV Cmax
The maximum concentration at steady state (Cmax) was measured.
Time frame: Week 48
Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV Treatment Group | Plasma RTV Cmax | 2 to <6 yrs, 3 mg/kg BID; n=0, 10 | 0.633 µg/mL |
| FPV/RTV Treatment Group | Plasma RTV Cmax | 6 to <12 yrs, 3 mg/kg BID; n=0, 14 | 1.100 µg/mL |
| FPV/RTV Treatment Group | Plasma RTV Cmax | 6 to <12.yrs, 100 mg BID; n=0, 6 | 0.980 µg/mL |
| FPV/RTV Treatment Group | Plasma RTV Cmax | 12 to 18 yrs, 3 mg/kg BID; n=0, 3 | 0.750 µg/mL |
| FPV/RTV Treatment Group | Plasma RTV Cmax | 12 to 18 yrs, 100 mg BID; n=0, 16 | 1.06 µg/mL |
Secondary
Plasma RTV Cτ
The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.
Time frame: Week 48
Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV Treatment Group | Plasma RTV Cτ | 2 to <6 yrs, 3 mg/kg BID; n=0, 16 | 0.224 µg/mL |
| FPV/RTV Treatment Group | Plasma RTV Cτ | 6 to <12 yrs, 3 mg/kg BID; n=0, 24 | 0.297 µg/mL |
| FPV/RTV Treatment Group | Plasma RTV Cτ | 6 to <12 yrs, 100 mg BID; n=0, 10 | 0.228 µg/mL |
| FPV/RTV Treatment Group | Plasma RTV Cτ | 12 to 18 yrs, 3 mg/kg BID; n=0, 6 | 0.263 µg/mL |
| FPV/RTV Treatment Group | Plasma RTV Cτ | 12 to 18 yrs, 100 mg BID; n=0, 41 | 0.220 µg/mL |
Secondary
Plasma RTV t1/2
alf-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.
Time frame: Week 48
Population: PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV Treatment Group | Plasma RTV t1/2 | 12 to 18 yrs, 3 mg/kg BID; n=0, 1 | 2.84 hours |
| FPV/RTV Treatment Group | Plasma RTV t1/2 | 12 to 18 yrs, 100 mg BID; n=0, 14 | 3.64 hours |
| FPV/RTV Treatment Group | Plasma RTV t1/2 | 2 to <6 yrs, 3 mg/kg BID; n=0, 10 | 3.43 hours |
| FPV/RTV Treatment Group | Plasma RTV t1/2 | 6 to <12 yrs, 3 mg/kg BID; n=0, 11 | 3.39 hours |
| FPV/RTV Treatment Group | Plasma RTV t1/2 | 6 to <12 yrs, 100 mg BID; n=0, 5 | 3.97 hours |
Secondary
Plasma RTV Tmax
The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax).
Time frame: Week 48
Population: PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV Treatment Group | Plasma RTV Tmax | 2 to <6 yrs, 3 mg/kg BID; n=0, 10 | 3.92 hours |
| FPV/RTV Treatment Group | Plasma RTV Tmax | 6 to <12 yrs, 3 mg/kg BID; n=0, 14 | 4.00 hours |
| FPV/RTV Treatment Group | Plasma RTV Tmax | 6 to <12 yrs, 100 mg BID; n=0, 6 | 4.01 hours |
| FPV/RTV Treatment Group | Plasma RTV Tmax | 12 to 18 yrs, 3 mg/kg BID; n=0, 3 | 5.92 hours |
| FPV/RTV Treatment Group | Plasma RTV Tmax | 12 to 18 yrs, 100 mg BID; n=0, 16 | 3.96 hours |