HIV Infections, Infection, Human Immunodeficiency Virus
Conditions
Keywords
pediatrics, ritonavir, amprenavir, AGENERASE, HIV, Lexiva, protease inhibitors, HIV Infection, fosamprenavir
Brief summary
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to \< 2 years old.
Detailed description
A 48 week, Phase II, open-label, 2-cohort, multicenter study to evaluate the pharmacokinetics, safety, tolerability and antiviral activity of GW433908 and GW433908/RTV when administered to HIV-1 infected protease inhibitor (PI) naive and PI-experienced pediatric subjects aged 4 weeks to \<2 years.
Interventions
DRUGGW433908
Fosamprenavir suspension 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
4 Weeks to 2 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 4 weeks to \<2 years of age. Cohort 1 (6 months - \<2 years): Subjects must be \<2 years of age at the Week 2 visit therefore the maximum age at screening is 22 months. Cohort 2 (4 weeks - \<6 months): Subjects must be \<6 months of age at the Week 2 visit, therefore the maximum age at screening is 4 months for entry into this cohort. * Parent or legal guardian is willing and able to provide written informed consent for the subject to participate in the trial. * Screening plasma HIV-1 RNA level \>=400copies/mL. * Subjects who, in the investigator's opinion, and following viral resistance testing if conducted, are able to construct an active Nucleoside Reverse Transcriptase Inhibitor (NRTI) backbone regimen consisting of 2 NRTIs. * Subjects must meet one of the following criteria: Therapy-naïve or PI-naïve subjects (defined as having received less than one week of any PI). PI-experienced subjects defined as having prior experience 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 agent.
Exclusion criteria
* Prior history of having received APV. * Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) therapy within 14 days prior to study drug administration (single or multiple dose) or anticipated need for concurrent NNRTI therapy during the study period. * PI therapy within 5 days prior to study drug administration (applicable only for subjects undergoing single dose visits) * Subjects and/or parents/legal guardians 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 infections, such treatment not being contraindicated with FPV, and 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. * Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia, diabetes, cardiac dysfunction, hepatitis, or clinically relevant pancreatitis) which, in the opinion of the investigator, might compromise the safety of the subject. * 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 would exclude a subject from study participation. * Grade 3 or higher (\>10x ULN) serum aminotransferase levels (alanine aminotransferase, ALT and/or aspartate aminotransferase, AST) within 28 days prior to study drug administration and / or clinically relevant hepatitis within the previous 6 months. * 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: Amiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam, lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone, propoxyphene, quinidine, simvastatin, terfenadine, and triazolam (these drugs have been excluded for safety reasons). Carbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort, (these drugs have been excluded because they have the potential to decrease plasma protease inhibitor concentrations). * Treatment with other investigational drugs/therapies within 28 days prior to receiving study medication (note: treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis in consultation with the sponsor). * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48 | Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol and triglyceride (TG). Clinical chemistry analyses were carried out using the observed analysis strategy. |
| Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 | Baseline (Day 1) and Weeks 4, 12, 24, and 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 the indicated time point minus the value at Baseline. |
| Number of Participants Who Permanently Discontinued the Treatment Due to an AE | Baseline (Day 1) until 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. |
| Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE) | Baseline (Day 1) until 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. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening. |
| Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Baseline (Day 1) until Week 48 | TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater 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. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening. |
| 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. hours, hr. |
| 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 mL/Min/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 mL/Min | 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 Unbound APV Cτ | Week 48 | Participants who are \<2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or free APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state. |
| Plasma Unbound APV Percent Protein Binding (%Cτ) | Week 48 | Participants who are \<2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound. |
| Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48 | Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Indicated Virological Outcome 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 (withdrew consent, loss to follow-up, moved, etc.). |
| Plasma Ritonavir (RTV) AUC (0-τ) | Week 48 | Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted 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. |
| 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 Expressed in mL/Min/kg | Week 48 | Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as 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 Expressed in mL/Min | Week 48 | Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). |
| Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Baseline through 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.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Baseline through Week 48 | 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 Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Weeks 2, 12, 24, and 48 | A separate questionnaire was administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit. |
| Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Weeks 2, 24, and 48/premature study discontinuation | P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G's perception of the child's assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit. |
| Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Weeks (W) 2, 24, and 48/premature study discontinuation | Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian's perception of the child's assessment of the oral suspension (Items: 5=reaction to new medicine \[med.\]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like. |
| 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 Expressed in mL/Min/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 Expressed in mL/Min | Week 48 | The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated. |
| Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or 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. |
| Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Baseline (Day 1) and up to Week 684 | Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. |
| Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Baseline (Day 1) and up to Week 684 | Blood samples of participants were collected to measure plasma HIV-1 RNA copies. Baseline value was defined as the value observed at the day 1 visit or if this value is missing the last value observed before the start of investigational product. Change from baseline value was defined as post-dose value minus baseline value. |
| Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Baseline (Day 1) and up to week 684 | Blood samples of participants were collected for the measurement of the CD4+ cells. |
| Plasma FPV Concentrations | Post -Week 48 through Week 684 | — |
| Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint | Week 48 to Week 684 | A blood sample was drawn from participants failing to respond to therapy, and genotyping was performed to identify the mutations present in the baseline (pre-therapy) and the sample obtained at virologic failure (VF). For each participant, the HIV-1 mutations found at the time of failure were compared with any HIV-1 mutations detected 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- NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Participants are grouped by study arm (prior therapy experience), results displayed in this table are from participants who met virologic failure criteria from Week 48 through Week 684. |
| Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility | Post-Week 48 to Week 684 | A blood sample was drawn from participant failing to respond to therapy, and the mutations present in the virus were identified. Phenotypic resistance was assessed for virologic failure population and evaluated for Protease Inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNTRIs) using Monogram PhenoSense Assay. Virologic failure was defined as having failed to achieve a plasma HIV-RNA of \<400 copies/mL by Week 24 or having had a confirmed HIV-RNA rebound to ≥400 c/mL at any time after achieving a plasma HIV-RNA of \<400 c/mL. |
| Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Baseline and Weeks 4, 12, 24, 36, and 48 | Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. 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 4, 12, 24, 36, and 48 (Observed Analysis) | Baseline and Weeks 4, 12, 24, 36, and 48 | Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. |
| Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Baseline and Weeks 4, 12, 24, 36, and 48 | Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline. |
| Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Baseline and Weeks 4, 12, 24, 36, and 48 | Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the 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 Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Baseline and Weeks 4, 12, 24, 36, 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. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV. |
| Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Baseline and Weeks 4, 12, 24, 36, 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 indicated time points minus the value at Baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Day 1 and up to week 684 | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event | Day 1 and up to Week 684 | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Number of Participants With Treatment Limiting Toxicities | Day 1 and up to Week 684 | Treatment limiting toxicities are defined as those that are related to investigational medicinal products and deemed to be unacceptable, leading to restriction of further dose escalation. |
| Number of Participants With Hematology Toxicities | Day 1 and up to Week 684 | Blood samples were collected for the analysis of all hematology parameters. Laboratory toxicities were graded using the DAIDS Table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 hematology toxicities is presented. |
| Number of Participants With Clinical Chemistry Toxicities | Day 1 and up to Week 684 | Blood samples were collected for the analysis of all clinical chemistry parameters. Laboratory toxicities were graded using the Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 clinical chemistry toxicities is presented. |
Countries
Argentina, Mexico, Portugal, Puerto Rico, Russia, South Africa, United States
Participant flow
Recruitment details
The study was conducted between 23-Oct-2003 to 29-March-2022 in Argentina, Mexico, Portugal and South Africa. The cut off date for 48 week primary endpoint was July 5th 2011.
Pre-assignment details
59 participants were enrolled in the study and received at least one dose of Fosamprenavir (FPV)/Ritonavir (RTV) (Safety Population). Five participants out of 59 only received single dose before discontinuing the study. 54 participants who received both single and multiple doses of FPV/RTV were included in Intent to Treat-Exposed (ITT-E) population.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1, Arm A - 6 Months to <2 Years Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID. | 28 |
| Cohort 2, Arm A - 4 Weeks to <6 Months Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID. | 26 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Insufficient Viral Load Response | 1 | 1 |
| Overall Study | Lack of availability of RTV | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Relocation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 1, Arm A - 6 Months to <2 Years | Cohort 2, Arm A - 4 Weeks to <6 Months | Total |
|---|---|---|---|
| Age, Continuous | 13.3 Months STANDARD_DEVIATION 5.6 | 3.4 Months STANDARD_DEVIATION 0.95 | 8.6 Months STANDARD_DEVIATION 6.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 0 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 26 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 13 Participants | 31 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 29 | 2 / 30 |
| other Total, other adverse events | 24 / 29 | 28 / 30 |
| serious Total, serious adverse events | 13 / 29 | 12 / 30 |
Outcome results
Primary
Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48
Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy.
Time frame: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48
Population: Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Day 1; n=26;30 | 22.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 4; n=23;28 | 14.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 12; n=22;27 | 15.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 24; n=22;26 | 16.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 36; n=20;25 | 15.5 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 48; n=18;24 | 15.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Day 1; n=26;30 | 43.5 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 4; n=23;28 | 32.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 12; n=22;27 | 35.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 24; n=22;26 | 34.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 36; n=20;24 | 35.0 International units per liter (IU/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 48; n=18;23 | 34.5 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 36; n=20;24 | 34.0 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Day 1; n=26;30 | 20.0 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Day 1; n=26;30 | 44.0 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 4; n=23;28 | 15.5 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 24; n=22;26 | 36.5 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 12; n=22;27 | 15.0 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 4; n=23;28 | 35.0 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 24; n=22;26 | 15.5 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 48; n=18;23 | 34.0 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 36; n=20;25 | 16.0 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | AST, Week 12; n=22;27 | 40.0 International units per liter (IU/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | ALT, Week 48; n=18;24 | 16.0 International units per liter (IU/L) |
Primary
Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48
Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol and triglyceride (TG). Clinical chemistry analyses were carried out using the observed analysis strategy.
Time frame: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48
Population: Safety Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Day 1; n=22;29 | 2.235 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 4; n=4;2 | 3.085 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 24; n=22;26 | 4.175 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 36; n=3;2 | 3.030 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 48; n=18;24 | 3.890 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Day 1; n=26;30 | 4.80 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 4; n=23;28 | 4.60 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 12; n=22;27 | 4.70 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 24; n=22;26 | 4.55 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 36; n=20;25 | 4.50 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 48; n=18;24 | 4.45 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Day 1; n=22;29 | 0.655 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 4; n=4;2 | 0.825 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 24; n=22;26 | 0.900 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 36; n=3;2 | 0.640 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 48; n=18;24 | 0.825 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Day 1; n=22;28 | 0.90 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 4; n=4;2 | 1.25 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 24; n=22;26 | 2.08 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 36; n=3;2 | 1.90 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 48; n=18;24 | 2.33 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Day 1; n=22;29 | 1.695 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 4; n=4;2 | 2.015 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 24; n=22;26 | 2.155 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 36; n=3;2 | 1.310 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 48; n=18;24 | 1.590 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 4; n=4;2 | 0.690 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 12; n=0;2 | 0.775 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 36; n=3;2 | 1.700 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 24; n=22;26 | 0.960 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 48; n=18;24 | 2.80 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Day 1; n=22;29 | 2.910 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 36; n=3;2 | 0.805 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 4; n=4;2 | 3.885 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 12; n=0;2 | 3.950 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 24; n=22;26 | 1.550 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 24; n=22;26 | 4.000 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Week 48; n=18;24 | 1.050 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 36; n=3;2 | 3.150 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Day 1; n=22;29 | 1.650 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Cholesterol, Week 48; n=18;24 | 4.750 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Day 1; n=22;28 | 1.50 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Day 1; n=26;30 | 4.70 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 48; n=18;24 | 1.390 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 4; n=23;28 | 4.80 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 4; n=4;2 | 2.45 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 12; n=22;27 | 4.70 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 12; n=0;2 | 2.33 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 24; n=22;26 | 4.30 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 4; n=4;2 | 1.645 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 36; n=20;25 | 4.60 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 24; n=22;26 | 2.32 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | Glucose, Week 48; n=18;24 | 4.70 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | TG, Week 12; n=0;2 | 1.810 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | HDL, Day 1; n=22;29 | 0.680 Millimoles per liter (mmol/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48 | LDL, Week 36; n=3;2 | 2.08 Millimoles per liter (mmol/L) |
Primary
Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 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 the indicated time point minus the value at Baseline.
Time frame: Baseline (Day 1) and Weeks 4, 12, 24, and 48
Population: Safety Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 | Week 48; n=1;8 | 16.0 Units per liter (U/L) |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 | Day 1; n=2;11 | 20.5 Units per liter (U/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 | Week 4; n=0;1 | 16.0 Units per liter (U/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 | Week 24; n=0;8 | 19.5 Units per liter (U/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 | Week 48; n=1;8 | 16.0 Units per liter (U/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 | Week 12; n=0;1 | 68.0 Units per liter (U/L) |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48 | Day 1; n=2;11 | 22.0 Units per liter (U/L) |
Primary
Number of Participants Who Permanently Discontinued the Treatment Due to an 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: Baseline (Day 1) until Week 48
Population: Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants Who Permanently Discontinued the Treatment Due to an AE | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants Who Permanently Discontinued the Treatment Due to an AE | 2 participants |
Primary
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (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. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.
Time frame: Baseline (Day 1) until Week 48
Population: Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE) | 11 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE) | 10 participants |
Primary
Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities
TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater 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. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.
Time frame: Baseline (Day 1) until Week 48
Population: Safety Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Clinical Chemistry Toxicities - Grade 3 | 2 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Hematology Toxicities - Grade 3 | 2 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Hematology Toxicities - Grade 4 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Clinical Chemistry Toxicities - Grade 4 | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Hematology Toxicities - Grade 4 | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Clinical Chemistry Toxicities - Grade 3 | 4 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Clinical Chemistry Toxicities - Grade 4 | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities | Hematology Toxicities - Grade 3 | 2 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. hours, hr.
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/RTV BID: 4 Weeks to <6 Months | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 45/7 mg/kg BID; n=2, 10 | 35.08 Hr per microgram/milliliter (hr*µg/mL) |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 60/10 mg/kg BID; n=2, 2 | 54.2 Hr per microgram/milliliter (hr*µg/mL) |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 45/10 mg/kg BID; n=9, 1 | 26.6 Hr per microgram/milliliter (hr*µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 60/7 mg/kg BID; n=0, 8 | 48.4 Hr per microgram/milliliter (hr*µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 60/10 mg/kg BID; n=2, 2 | 26.22 Hr per microgram/milliliter (hr*µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 45/10 mg/kg BID; n=9, 1 | 64.51 Hr per microgram/milliliter (hr*µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Amprenavir (APV) AUC (0-tau[τ]) | 45/7 mg/kg BID; n=2, 10 | 27.5 Hr per microgram/milliliter (hr*µg/mL) |
Primary
Plasma APV CL/F Following Dosing Expressed in mL/Min
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/RTV BID: 4 Weeks to <6 Months | Plasma APV CL/F Following Dosing Expressed in mL/Min | 45/7 mg/kg BID; n=2, 10 | 106.7 mL/min |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV CL/F Following Dosing Expressed in mL/Min | 60/10 mg/kg BID; n=2, 2 | 86.4 mL/min |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV CL/F Following Dosing Expressed in mL/Min | 45/10 mg/kg BID; n=9, 1 | 135 mL/min |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV CL/F Following Dosing Expressed in mL/Min | 60/7 mg/kg BID; n=0, 8 | 172 mL/min |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV CL/F Following Dosing Expressed in mL/Min | 60/10 mg/kg BID; n=2, 2 | 234.3 mL/min |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV CL/F Following Dosing Expressed in mL/Min | 45/10 mg/kg BID; n=9, 1 | 62.5 mL/min |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV CL/F Following Dosing Expressed in mL/Min | 45/7 mg/kg BID; n=2, 10 | 190 mL/min |
Primary
Plasma APV CL/F Following Dosing Expressed in mL/Min/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/RTV BID: 4 Weeks to <6 Months | Plasma APV CL/F Following Dosing Expressed in mL/Min/kg | 45/7 mg/kg BID; n=2, 10 | 17.50 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV CL/F Following Dosing Expressed in mL/Min/kg | 60/10 mg/kg BID; n=2, 2 | 15.3 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV CL/F Following Dosing Expressed in mL/Min/kg | 45/10 mg/kg BID; n=9, 1 | 22.9 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV CL/F Following Dosing Expressed in mL/Min/kg | 60/7 mg/kg BID; n=0, 8 | 17.8 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV CL/F Following Dosing Expressed in mL/Min/kg | 60/10 mg/kg BID; n=2, 2 | 31.92 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV CL/F Following Dosing Expressed in mL/Min/kg | 45/10 mg/kg BID; n=9, 1 | 10.42 Milliliters/minute/kilogram (mL/min/kg) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV CL/F Following Dosing Expressed in mL/Min/kg | 45/7 mg/kg BID; n=2, 10 | 22.8 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 (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV Cmax | 45/7 mg/kg BID; n=2, 10 | 8.20 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV Cmax | 60/10 mg/kg BID; n=2, 2 | 10.44 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV Cmax | 45/10 mg/kg BID; n=9, 1 | 6.25 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV Cmax | 60/7 mg/kg BID; n=0, 9 | 10.4 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV Cmax | 60/10 mg/kg BID; n=2, 2 | 7.47 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV Cmax | 45/10 mg/kg BID; n=9, 1 | 21.82 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV Cmax | 45/7 mg/kg BID; n=2, 10 | 5.84 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/RTV BID: 4 Weeks to <6 Months | Plasma APV Cτ | 45/7 mg/kg BID; n=3, 29 | 0.44 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV Cτ | 60/10 mg/kg BID; n=3, 5 | 0.60 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma APV Cτ | 45/10 mg/kg BID; n=11, 15 | 0.86 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV Cτ | 60/7 mg/kg BID; n=0, 12 | 2.81 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV Cτ | 60/10 mg/kg BID; n=3, 5 | 2.58 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV Cτ | 45/10 mg/kg BID; n=11, 15 | 1.92 Micrograms per milliliter (µg/mL) |
| FPV/RTV BID: 6 Months to <2 Years | Plasma APV Cτ | 45/7 mg/kg BID; n=3, 29 | 2.17 Micrograms per milliliter (µg/mL) |
Primary
Plasma Unbound APV Cτ
Participants who are \<2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or free APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state.
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Unbound APV Cτ | 45/7 mg/kg BID; n=1, 16 | 0.027 µg/mL | — |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Unbound APV Cτ | 60/10 mg/kg BID; n=1, 7 | 0.003 µg/mL | — |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Unbound APV Cτ | 45/10 mg/kg BID; n=7, 16 | 0.091 µg/mL | Standard Deviation 0.083 |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Unbound APV Cτ | 60/7 mg/kg BID; n=0, 12 | 0.290 µg/mL | Standard Deviation 0.31 |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Unbound APV Cτ | 60/10 mg/kg BID; n=1, 7 | 0.069 µg/mL | Standard Deviation 0.052 |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Unbound APV Cτ | 45/10 mg/kg BID; n=7, 16 | 0.087 µg/mL | Standard Deviation 0.076 |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Unbound APV Cτ | 45/7 mg/kg BID; n=1, 16 | 0.150 µg/mL | Standard Deviation 0.086 |
Primary
Plasma Unbound APV Percent Protein Binding (%Cτ)
Participants who are \<2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Unbound APV Percent Protein Binding (%Cτ) | 45/7 mg/kg BID; n=1, 16 | 7.55 Percentage of total APV Cτ unbound | — |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Unbound APV Percent Protein Binding (%Cτ) | 60/10 mg/kg BID; n=1, 7 | 5.32 Percentage of total APV Cτ unbound | — |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Unbound APV Percent Protein Binding (%Cτ) | 45/10 mg/kg BID; n=7, 15 | 5.79 Percentage of total APV Cτ unbound | Standard Deviation 2.05 |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Unbound APV Percent Protein Binding (%Cτ) | 60/7 mg/kg BID; n=0, 9 | 9.20 Percentage of total APV Cτ unbound | Standard Deviation 5.39 |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Unbound APV Percent Protein Binding (%Cτ) | 60/10 mg/kg BID; n=1, 7 | 5.81 Percentage of total APV Cτ unbound | Standard Deviation 1.68 |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Unbound APV Percent Protein Binding (%Cτ) | 45/10 mg/kg BID; n=7, 15 | 6.56 Percentage of total APV Cτ unbound | Standard Deviation 2.27 |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Unbound APV Percent Protein Binding (%Cτ) | 45/7 mg/kg BID; n=1, 16 | 8.23 Percentage of total APV Cτ unbound | Standard Deviation 8.67 |
Secondary
Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit
Blood samples of participants were collected for the measurement of the CD4+ cells.
Time frame: Baseline (Day 1) and up to week 684
Population: Intent to treat- exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 312 | 924 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 48 | 1690 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 324 | 980 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 144 | 1250 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 336 | 856 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 456 | 1003 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 348 | 1030 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 156 | 1422 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 360 | 1151 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 60 | 1890 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 372 | 1051 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 168 | 1550 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 384 | 950 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 12 | 1405 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 396 | 971 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 180 | 1331.5 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 408 | 1005 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 72 | 1407 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 420 | 840 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 444 | 811 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 192 | 1339 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 468 | 910 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Baseline (Day 1) | 1378 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 480 | 1063.5 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 204 | 1160 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 492 | 839 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 84 | 1560 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 504 | 887 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 216 | 1336 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 516 | 776 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 24 | 1595 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 528 | 860 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 228 | 1136 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 540 | 851 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 96 | 1530 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 552 | 756 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 240 | 1132.5 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 564 | 908 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 432 | 940.5 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 576 | 792 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 252 | 1379 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 588 | 873 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 108 | 1440 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 600 | 865.5 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 264 | 1109 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 612 | 720 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 36 | 1780 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 624 | 753 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 276 | 1180.5 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 636 | 770 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 120 | 1480 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 648 | 720 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 288 | 1063 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 660 | 750 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 4 | 1610 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 300 | 1062 Cells/cubic millimeter |
| FPV/RTV BID: 4 Weeks to <6 Months | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 132 | 1285 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 672 | 710 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 420 | 850 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 684 | 580 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 432 | 918 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 444 | 860 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Baseline (Day 1) | 1120 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 4 | 1734.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 12 | 1822 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 24 | 1475.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 36 | 1523 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 48 | 1602 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 60 | 1311 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 72 | 1667 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 84 | 1490.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 96 | 1460 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 108 | 1343.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 120 | 1148.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 132 | 1440 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 144 | 1562 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 156 | 1307 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 168 | 1236 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 180 | 978 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 192 | 1327 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 204 | 1082 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 216 | 909 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 228 | 1106 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 240 | 1067 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 252 | 1098.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 264 | 853 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 276 | 970 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 288 | 911.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 300 | 990 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 312 | 928.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 324 | 1242 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 336 | 1160 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 348 | 976 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 360 | 962 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 372 | 926 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 384 | 884 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 396 | 900 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 408 | 938.5 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 456 | 832 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 468 | 863 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 480 | 1010 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 492 | 930 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 504 | 910 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 516 | 994 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 528 | 892 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 540 | 877 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 552 | 1000 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 564 | 804 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 576 | 990 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 588 | 1100 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 600 | 717 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 612 | 949 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 624 | 720 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 636 | 535 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 648 | 455 Cells/cubic millimeter |
| FPV/RTV BID: 6 Months to <2 Years | Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit | Week 660 | 610 Cells/cubic millimeter |
Secondary
Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit
Blood samples of participants were collected to measure plasma HIV-1 RNA copies. Baseline value was defined as the value observed at the day 1 visit or if this value is missing the last value observed before the start of investigational product. Change from baseline value was defined as post-dose value minus baseline value.
Time frame: Baseline (Day 1) and up to Week 684
Population: Intent to treat-exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 504 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 4 | -2.38 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 12 | -3.11 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 24 | -3.77 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 36 | -3.72 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 48 | -3.90 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 60 | -3.89 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 72 | -3.95 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 84 | -3.95 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 96 | -4.26 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 108 | -4.26 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 120 | -4.12 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 132 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 144 | -4.12 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 156 | -4.12 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 168 | -3.95 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 180 | -4.36 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 192 | -4.28 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 204 | -4.22 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 216 | -4.36 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 228 | -4.45 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 240 | -4.22 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 252 | -4.22 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 264 | -4.22 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 276 | -4.22 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 288 | -4.22 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 300 | -4.22 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 312 | -4.05 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 324 | -4.01 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 336 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 348 | -4.33 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 360 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 372 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 384 | -4.01 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 396 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 408 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 420 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 432 | -4.33 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 444 | -4.04 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 456 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 468 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 480 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 492 | -3.55 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 516 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 528 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 540 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 552 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 564 | -4.28 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 576 | -4.04 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 588 | -4.04 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 600 | -3.55 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 612 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 624 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 636 | -4.00 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 648 | -4.00 Log10 copies/milliliter |
| FPV/RTV BID: 4 Weeks to <6 Months | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 660 | -4.09 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 324 | -3.87 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 636 | -4.27 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 336 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 72 | -3.60 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 516 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 4 | -2.33 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 348 | -3.36 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 12 | -3.14 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 600 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 24 | -3.38 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 360 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 36 | -3.52 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 528 | -3.80 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 48 | -3.56 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 372 | -3.36 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 60 | -3.12 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 660 | -4.27 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 384 | -3.15 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 84 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 540 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 96 | -3.70 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 396 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 108 | -3.80 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 612 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 120 | -3.58 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 408 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 132 | -3.52 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 552 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 144 | -3.52 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 420 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 156 | -3.34 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 648 | -4.27 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 168 | -3.52 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 432 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 180 | -3.52 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 564 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 192 | -3.31 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 444 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 204 | -3.52 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 624 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 216 | -3.52 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 456 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 228 | -3.71 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 576 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 240 | -3.71 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 468 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 252 | -3.71 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 672 | -4.27 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 264 | -3.71 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 480 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 276 | -3.71 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 588 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 288 | -3.71 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 492 | -3.62 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 300 | -3.80 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 684 | -3.99 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 312 | -3.98 Log10 copies/milliliter |
| FPV/RTV BID: 6 Months to <2 Years | Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit | Week 504 | -3.62 Log10 copies/milliliter |
Secondary
Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or 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 Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.
Time frame: Baseline and Weeks 4, 12, 24, 36, and 48
Population: ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 12, n=22;27 | -3.11 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 36, n=21;25 | -3.72 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 24, n=22;25 | -3.77 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 48, n=18;24 | -3.90 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 4, n=21;28 | -2.38 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 48, n=18;24 | -3.56 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 4, n=21;28 | -2.33 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 12, n=22;27 | -3.14 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 24, n=22;25 | -3.38 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 36, n=21;25 | -3.52 log10 copies/mL |
Secondary
Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, 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 indicated time points minus the value at Baseline.
Time frame: Baseline and Weeks 4, 12, 24, 36, and 48
Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. Not all participants had values at both baseline and the indicated time points; thus, change from baseline could not be calculated for all participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 12, n=19;27 | 2 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 36, n=18;25 | 8 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 24, n=19;26 | 7 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 48, n=15;24 | 5 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 4, n=20;28 | 3 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 48, n=15;24 | 4.7 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 4, n=20;28 | 3.4 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 12, n=19;27 | 6 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 24, n=19;26 | 6 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48 | Week 36, n=18;25 | 5 Percentage of cells |
Secondary
Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, 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. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A 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 4, 12, 24, 36, and 48
Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Baseline, n=23;28 | 27 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 4, n=23;28 | 29 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 12, n=22;27 | 27.5 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 24, n=22;26 | 31.5 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 36, n=21;25 | 32 Percentage of cells |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 48, n=18;24 | 28 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 36, n=21;25 | 29.5 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Baseline, n=23;28 | 25 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 24, n=22;26 | 32.8 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 4, n=23;28 | 27.5 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 48, n=18;24 | 31.6 Percentage of cells |
| FPV/RTV BID: 6 Months to <2 Years | Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48 | Week 12, n=22;27 | 32 Percentage of cells |
Secondary
Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.
Time frame: Baseline and Weeks 4, 12, 24, 36, and 48
Population: ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Baseline, n=26;28 | 5.80 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 4, n=21;28 | 3.29 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 12, n=22;27 | 2.28 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 24, n=22;25 | 1.69 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 36, n=21;25 | 1.69 log10 copies/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 48, n=18;24 | 1.69 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 36, n=21;25 | 1.69 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Baseline, n=26;28 | 5.51 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 24, n=22;25 | 1.74 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 4, n=21;28 | 2.88 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 48, n=18;24 | 1.69 log10 copies/mL |
| FPV/RTV BID: 6 Months to <2 Years | Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis) | Week 12, n=22;27 | 2.07 log10 copies/mL |
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: Baseline through 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/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NRTI Mutation | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NRTI mutation M184V | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | 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 BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation K101K/E | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | 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 BID: 4 Weeks to <6 Months | 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/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10F | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10I | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | 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/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33F | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | 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 BID: 6 Months to <2 Years | 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 BID: 6 Months to <2 Years | 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 BID: 6 Months to <2 Years | 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 BID: 6 Months to <2 Years | 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 BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33F | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10I | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | 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 BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10F | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation K101K/E | 0 participants |
| PI-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10I | 0 participants |
| PI-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | HIV NNRTI Mutation K101K/E | 1 participants |
| PI-Experienced | 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 |
| PI-Experienced | 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 | 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 | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L10F | 1 participants |
| PI-Experienced | 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-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Minor HIV PI Mutation L33F | 1 participants |
| PI-Experienced | 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-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease | Any HIV NNRTI Mutation | 1 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 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 phenotype at both baseline and the indicated time of VF points were evaluable
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir-boosted Fosamprenavir | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir-boosted Fosamprenavir | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 0 participants |
| PI-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Emtricitabine | 0 participants |
| PI-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Lamivudine | 0 participants |
| PI-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Ritonavir-boosted Fosamprenavir | 1 participants |
| PI-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NNRTI | 0 participants |
| PI-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any NRTI | 0 participants |
| PI-Experienced | Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS) | Any PI | 1 participants |
Secondary
Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire
A separate questionnaire was administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.
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/RTV BID: 4 Weeks to <6 Months | Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Week 2 | 18 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Week 24 | 19 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Week 48 | 13 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Week 12 | 17 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Week 48 | 17 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Week 2 | 24 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Week 12 | 24 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire | Week 24 | 21 participants |
Secondary
Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)
Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the 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 4, 12, 24, 36, and 48
Population: ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 12 | 21 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 36 | 19 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 24 | 21 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 48 | 16 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 4 | 16 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 48 | 21 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 4 | 25 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 12 | 25 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 24 | 23 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis) | Week 36 | 22 participants |
Secondary
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)
Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. 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 4, 12, 24, 36, and 48
Population: Intent-to-Treat Exposed (ITT-E) Population: participants who received chronic therapy with FPV or FPV/RTV at any dose. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Baseline | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 4 | 5 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 12 | 13 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 24 | 18 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 36 | 19 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 48 | 15 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 36 | 20 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Baseline | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 24 | 20 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 4 | 6 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 48 | 22 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F) | Week 12 | 18 participants |
Secondary
Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit
Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations.
Time frame: Baseline (Day 1) and up to Week 684
Population: Intent to treat- exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 168 | 12 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 348 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 84 | 14 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 360 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 180 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 372 | 11 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 4 | 5 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 384 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 192 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 396 | 11 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 96 | 15 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 408 | 11 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 204 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 420 | 8 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 48 | 15 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 432 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 216 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 444 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 108 | 15 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 456 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 228 | 12 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 468 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 24 | 18 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 480 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 240 | 12 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 492 | 7 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 120 | 14 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 504 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 252 | 12 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 516 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 60 | 15 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 528 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 264 | 12 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 540 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 132 | 14 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 552 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 276 | 12 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 564 | 6 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 12 | 13 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 576 | 6 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 288 | 12 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 588 | 6 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 144 | 14 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 600 | 5 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 300 | 12 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 612 | 5 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 72 | 14 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 624 | 5 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 312 | 10 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 636 | 1 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 156 | 14 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 648 | 1 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 324 | 11 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 660 | 1 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 36 | 19 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 672 | 0 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 336 | 11 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 684 | 0 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Baseline (Day 1) | 1 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 684 | 1 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Baseline (Day 1) | 0 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 4 | 6 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 12 | 18 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 24 | 20 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 36 | 20 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 48 | 22 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 60 | 12 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 72 | 14 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 84 | 15 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 96 | 14 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 108 | 14 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 120 | 11 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 132 | 11 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 144 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 156 | 10 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 168 | 9 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 180 | 9 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 192 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 204 | 9 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 216 | 9 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 228 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 240 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 252 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 264 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 276 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 288 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 300 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 312 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 324 | 8 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 336 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 348 | 6 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 360 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 372 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 384 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 396 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 408 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 420 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 432 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 444 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 456 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 468 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 480 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 492 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 504 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 516 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 528 | 6 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 540 | 5 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 552 | 5 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 564 | 5 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 576 | 5 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 588 | 5 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 600 | 3 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 612 | 3 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 624 | 3 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 636 | 2 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 648 | 2 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 660 | 2 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit | Week 672 | 2 Participants |
Secondary
Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10
Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian's perception of the child's assessment of the oral suspension (Items: 5=reaction to new medicine \[med.\]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like.
Time frame: Weeks (W) 2, 24, and 48/premature study discontinuation
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 7, problem taking most of time, n=15;22 | 2 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 6, dislike, n=20;23 | 11 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 7, impossible to take, n=15;22 | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 5, takes all/most med. easily, n=23;27 | 10 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 8, swallows with no problem, n=23;27 | 9 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 6, neutral, n=20;23 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 8, swallows with struggle, n=23;27 | 11 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 6, like, n=20;23 | 6 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 8, spits out suspension, n=23;27 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 5, takes all/most med. easily, n=14;22 | 10 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 8, vomits the suspension, n=23;27 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 6, dislike, n=15;22 | 9 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 8, swallows with no problem, n=20;23 | 10 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 5, takes all/most med. easily, n=20;23 | 12 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 8, swallows with struggle, n=20;23 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 6, neutral, n=15;22 | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 8, spits out suspension, n=20;23 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 48, Item 5, problem taking a few med., n=14;22 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 8, vomits the suspension, n=20;23 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 6, like, n=15;22 | 5 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 8, swallows with no problem, n=15;22 | 11 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 5, problem taking most med., n=23;27 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 8, swallows with struggle, n=15;22 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 7, no problem taking FPV, n=23;27 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 8, spits out suspension, n=15;22 | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 5, problem taking most med., n=14;22 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 8, vomits the suspension, n=15;22 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 7, few problems taking FPV, n=23;27 | 9 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, I9, take more willingly than other med., n=23;27 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 5, problem taking a few med., n=20;23 | 8 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 9, about the same, n=23;27 | 13 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 7, problem taking most of time, n=23;27 | 5 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, I9, not as willing to take as other med., n=23;27 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 5, impossible to take med., n=14;22 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, I9, take more willingly than other med., n=20;22 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 7, impossible to take, n=23;27 | 2 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 9, about the same, n=20;22 | 11 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 5, problem taking a few med., n=23;27 | 10 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, I9, not as willing to take as other med, n=20;22 | 6 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 7, no problem taking FPV, n=20;23 | 13 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, I9, take more willingly than other med., n=15;22 | 5 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 6, dislike, n=23;27 | 12 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 9, about the same, n=15;22 | 10 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 7, few problems taking FPV, n=20;23 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, I9, not as willing to take as other med, n=15;22 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 5, problem taking most med., n=20;23 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 2, Item 10, dislike, n=23;27 | 11 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 7, problem taking most of time, n=20;23 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 2, Item 10, neutral, n=23;27 | 5 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 6, neutral, n=23;27 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 2, Item 10, like, n=23;27 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 7, impossible to take, n=20;23 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 24, Item 10, dislike, n=20;24 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 5, impossible to take med., n=23;27 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 24, Item 10, neutral, n=20;24 | 2 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 7, no problem taking FPV, n=15;22 | 8 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 48, Item 10, dislike, n=15;22 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 6, like, n=23;27 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 48, Item 10, neutral, n=15;22 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 7, few problems taking FPV, n=15;22 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 48, Item 10, like, n=15;22 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 5, impossible to take med., n=20;23 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 24, Item 10, like, n=20;24 | 11 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 6, neutral, n=20;23 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 24, Item 10, like, n=20;24 | 4 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 5, takes all/most med. easily, n=23;27 | 11 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 5, problem taking a few med., n=23;27 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 5, problem taking most med., n=23;27 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 5, impossible to take med., n=23;27 | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 5, takes all/most med. easily, n=20;23 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 5, problem taking a few med., n=20;23 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 5, problem taking most med., n=20;23 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 5, impossible to take med., n=20;23 | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 5, takes all/most med. easily, n=14;22 | 17 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 48, Item 5, problem taking a few med., n=14;22 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 5, problem taking most med., n=14;22 | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 5, impossible to take med., n=14;22 | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 6, dislike, n=23;27 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 6, neutral, n=23;27 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 6, like, n=23;27 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 6, dislike, n=20;23 | 12 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 6, like, n=20;23 | 6 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 6, dislike, n=15;22 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 6, neutral, n=15;22 | 6 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 6, like, n=15;22 | 6 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 7, no problem taking FPV, n=23;27 | 6 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 7, few problems taking FPV, n=23;27 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 7, problem taking most of time, n=23;27 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 7, impossible to take, n=23;27 | 2 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 7, no problem taking FPV, n=20;23 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 7, few problems taking FPV, n=20;23 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 7, problem taking most of time, n=20;23 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 7, impossible to take, n=20;23 | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 7, no problem taking FPV, n=15;22 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 7, few problems taking FPV, n=15;22 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 7, problem taking most of time, n=15;22 | 2 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 7, impossible to take, n=15;22 | 2 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 8, swallows with no problem, n=23;27 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 8, swallows with struggle, n=23;27 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 8, spits out suspension, n=23;27 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 8, vomits the suspension, n=23;27 | 2 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 8, swallows with no problem, n=20;23 | 12 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 8, swallows with struggle, n=20;23 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 8, spits out suspension, n=20;23 | 2 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 8, vomits the suspension, n=20;23 | 0 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 8, swallows with no problem, n=15;22 | 12 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 8, swallows with struggle, n=15;22 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 8, spits out suspension, n=15;22 | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 8, vomits the suspension, n=15;22 | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, I9, take more willingly than other med., n=23;27 | 3 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, Item 9, about the same, n=23;27 | 15 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W2, I9, not as willing to take as other med., n=23;27 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, I9, take more willingly than other med., n=20;22 | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, Item 9, about the same, n=20;22 | 20 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W24, I9, not as willing to take as other med, n=20;22 | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, I9, take more willingly than other med., n=15;22 | 6 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, Item 9, about the same, n=15;22 | 14 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | W48, I9, not as willing to take as other med, n=15;22 | 2 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 2, Item 10, dislike, n=23;27 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 2, Item 10, neutral, n=23;27 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 2, Item 10, like, n=23;27 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 24, Item 10, dislike, n=20;24 | 13 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 24, Item 10, neutral, n=20;24 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 48, Item 10, dislike, n=15;22 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 48, Item 10, neutral, n=15;22 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10 | Week 48, Item 10, like, n=15;22 | 7 participants |
Secondary
Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4
P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G's perception of the child's assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit.
Time frame: Weeks 2, 24, and 48/premature study discontinuation
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, odor, dislike, n=23;27 | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, color, like, n=20;24 | 14 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, odor, neutral, n=23;27 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, texture, neutral, n=23;27 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, odor, like, n=23;27 | 19 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, color, dislike, n=20;24 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, odor, dislike, n=20;24 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, texture, like, n=23;27 | 12 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, odor, neutral, n=20;24 | 2 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, color, dislike, n=15;22 | 6 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, odor, like, n=20;24 | 14 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, texture, dislike, n=20;24 | 6 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, odor, dislike, n=15;22 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, color, like, n=23;27 | 13 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, odor, neutral, n=15;22 | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, texture, neutral, n=20;24 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, odor, like, n=15;22 | 10 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, color, neutral, n=15;22 | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, general satisfaction, dislike, n=23;27 | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, texture, like, n=20;24 | 10 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, general satisfaction, neutral, n=23;27 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, color, neutral, n=20;24 | 2 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, general satisfaction, like, n=23;27 | 16 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, texture, dislike, n=15;21 | 6 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, general satisfaction, dislike, n=20;24 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, color, like, n=15;22 | 8 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, general satisfaction, neutral, n=20;24 | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, texture, neutral, n=15;21 | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, general satisfaction, like, n=20;24 | 16 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, color, neutral, n=23;27 | 7 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, general satisfaction, dislike, n=15;22 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, texture, like, n=15;21 | 8 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, general satisfaction, neutral, n=15;22 | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, texture, dislike, n=23;27 | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, general satisfaction, like, n=15;22 | 10 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, color, dislike, n=23;27 | 3 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, general satisfaction, like, n=15;22 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, color, dislike, n=23;27 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, color, neutral, n=23;27 | 13 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, color, like, n=23;27 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, color, dislike, n=20;24 | 4 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, color, neutral, n=20;24 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, color, like, n=20;24 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, color, dislike, n=15;22 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, color, neutral, n=15;22 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, color, like, n=15;22 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, texture, dislike, n=23;27 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, texture, neutral, n=23;27 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, texture, like, n=23;27 | 12 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, texture, dislike, n=20;24 | 4 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, texture, neutral, n=20;24 | 12 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, texture, like, n=20;24 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, texture, dislike, n=15;21 | 6 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, texture, neutral, n=15;21 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, texture, like, n=15;21 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, odor, dislike, n=23;27 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, odor, neutral, n=23;27 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, odor, like, n=23;27 | 13 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, odor, dislike, n=20;24 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, odor, neutral, n=20;24 | 8 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, odor, like, n=20;24 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, odor, dislike, n=15;22 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, odor, neutral, n=15;22 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, odor, like, n=15;22 | 10 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, general satisfaction, dislike, n=23;27 | 5 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, general satisfaction, neutral, n=23;27 | 7 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 2, general satisfaction, like, n=23;27 | 15 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, general satisfaction, dislike, n=20;24 | 6 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, general satisfaction, neutral, n=20;24 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 24, general satisfaction, like, n=20;24 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, general satisfaction, dislike, n=15;22 | 9 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4 | Week 48, general satisfaction, neutral, n=15;22 | 4 participants |
Secondary
Number of Participants With the Indicated Virological Outcome 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 (withdrew consent, loss to follow-up, moved, etc.).
Time frame: Week 48
Population: ITT-E Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Virological Outcome at Week 48 | V failure (2) | 0 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Virological Outcome at Week 48 | V failure (4) | 2 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Virological Outcome at Week 48 | V failure (1) | 3 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Virological Outcome at Week 48 | No V data at Week 48 (a) | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Virological Outcome at Week 48 | V failure (3) | 1 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Virological Outcome at Week 48 | No V data at Week 48 (b) | 4 participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With the Indicated Virological Outcome at Week 48 | Virological (V) success | 15 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Virological Outcome at Week 48 | No V data at Week 48 (b) | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Virological Outcome at Week 48 | Virological (V) success | 20 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Virological Outcome at Week 48 | V failure (1) | 2 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Virological Outcome at Week 48 | V failure (2) | 2 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Virological Outcome at Week 48 | V failure (3) | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Virological Outcome at Week 48 | V failure (4) | 1 participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With the Indicated Virological Outcome at Week 48 | No V data at Week 48 (a) | 1 participants |
Secondary
Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility
A blood sample was drawn from participant failing to respond to therapy, and the mutations present in the virus were identified. Phenotypic resistance was assessed for virologic failure population and evaluated for Protease Inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNTRIs) using Monogram PhenoSense Assay. Virologic failure was defined as having failed to achieve a plasma HIV-RNA of \<400 copies/mL by Week 24 or having had a confirmed HIV-RNA rebound to ≥400 c/mL at any time after achieving a plasma HIV-RNA of \<400 c/mL.
Time frame: Post-Week 48 to Week 684
Population: Virological failure population includes participants who met the protocol definition of definition of virologic failure and for whom an HIV-1 phenotype was obtained at both the baseline (pre-therapy) and at the virologic failure timepoints. No participants in this time frame were PI-experienced, therefore data was not collected for the PI-Experienced Arm/Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility | Treatment emergent reduced NRTI drug susceptibility | 0 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility | Treatment emergent reduced NNRTI drug susceptibility | 0 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility | Treatment emergent reduced PI drug susceptibility | 0 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility | Treatment emergent reduced NRTI drug susceptibility | 0 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility | Treatment emergent reduced NNRTI drug susceptibility | 0 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility | Treatment emergent reduced PI drug susceptibility | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint
A blood sample was drawn from participants failing to respond to therapy, and genotyping was performed to identify the mutations present in the baseline (pre-therapy) and the sample obtained at virologic failure (VF). For each participant, the HIV-1 mutations found at the time of failure were compared with any HIV-1 mutations detected 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- NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Participants are grouped by study arm (prior therapy experience), results displayed in this table are from participants who met virologic failure criteria from Week 48 through Week 684.
Time frame: Week 48 to Week 684
Population: VF population included participants who failed 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 data. Only participants with an HIV-1 genotype which obtained for both the baseline and the indicated time of VF points were evaluable. No participants in this time frame were PI-experienced, therefore data was not collected for the PI-Experienced Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint | PRO, L10L/R | 1 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint | PRO, I62I/V | 1 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint | PRO, L10L/R | 0 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint | PRO, I62I/V | 0 Participants |
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 Expressed in mL/Min
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 Expressed in mL/Min/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 Concentrations
Time frame: Post -Week 48 through Week 684
Population: All PK data collected through 5 July 2011 were included in the 48-week analysis results, no data was subsequently collected.
Secondary
Plasma Ritonavir (RTV) AUC (0-τ)
Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted 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. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Ritonavir (RTV) AUC (0-τ) | 7 mg/kg BID; n=2, 22 | 1.921 hr*µg/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma Ritonavir (RTV) AUC (0-τ) | 10 mg/kg BID; n=11, 2 | 12.952 hr*µg/mL |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Ritonavir (RTV) AUC (0-τ) | 7 mg/kg BID; n=2, 22 | 7.363 hr*µg/mL |
| FPV/RTV BID: 6 Months to <2 Years | Plasma Ritonavir (RTV) AUC (0-τ) | 10 mg/kg BID; n=11, 2 | 18.750 hr*µg/mL |
Secondary
Plasma RTV CL/F Expressed in mL/Min
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).
Time frame: Week 48
Population: PK Population. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma RTV CL/F Expressed in mL/Min | 7 mg/kg BID, n=2, 22 | 335.2 mL/min |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma RTV CL/F Expressed in mL/Min | 10 mg/kg BID, n=11, 2 | 72.1 mL/min |
| FPV/RTV BID: 6 Months to <2 Years | Plasma RTV CL/F Expressed in mL/Min | 7 mg/kg BID, n=2, 22 | 134.1 mL/min |
| FPV/RTV BID: 6 Months to <2 Years | Plasma RTV CL/F Expressed in mL/Min | 10 mg/kg BID, n=11, 2 | 57.9 mL/min |
Secondary
Plasma RTV CL/F Expressed in mL/Min/kg
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as 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. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma RTV CL/F Expressed in mL/Min/kg | 7 mg/kg BID, n=2, 22 | 58.668 mL/min/kg |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma RTV CL/F Expressed in mL/Min/kg | 10 mg/kg BID, n=11, 2 | 12.118 mL/min/kg |
| FPV/RTV BID: 6 Months to <2 Years | Plasma RTV CL/F Expressed in mL/Min/kg | 7 mg/kg BID, n=2, 22 | 14.960 mL/min/kg |
| FPV/RTV BID: 6 Months to <2 Years | Plasma RTV CL/F Expressed in mL/Min/kg | 10 mg/kg BID, n=11, 2 | 8.938 mL/min/kg |
Secondary
Plasma RTV 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/RTV BID: 4 Weeks to <6 Months | Plasma RTV Cmax | 7 mg/kg BID, n=2, 23 | 0.404 µg/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma RTV Cmax | 10 mg/kg BID, n=12, 2 | 2.388 µg/mL |
| FPV/RTV BID: 6 Months to <2 Years | Plasma RTV Cmax | 7 mg/kg BID, n=2, 23 | 1.576 µg/mL |
| FPV/RTV BID: 6 Months to <2 Years | Plasma RTV Cmax | 10 mg/kg BID, n=12, 2 | 3.823 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. Only those participants contributing data were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma RTV Cτ | 7 mg/kg BID, n=4, 33 | 0.0795 µg/mL |
| FPV/RTV BID: 4 Weeks to <6 Months | Plasma RTV Cτ | 10 mg/kg BID, n=15, 19 | 0.1855 µg/mL |
| FPV/RTV BID: 6 Months to <2 Years | Plasma RTV Cτ | 7 mg/kg BID, n=4, 33 | 0.2468 µg/mL |
| FPV/RTV BID: 6 Months to <2 Years | Plasma RTV Cτ | 10 mg/kg BID, n=15, 19 | 0.4200 µg/mL |
Other Pre-specified
Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Day 1 and up to Week 684
Population: Intent-to-Treat exposed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event | 1 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event | 1 Participants |
Other Pre-specified
Number of Participants With Clinical Chemistry Toxicities
Blood samples were collected for the analysis of all clinical chemistry parameters. Laboratory toxicities were graded using the Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 clinical chemistry toxicities is presented.
Time frame: Day 1 and up to Week 684
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Clinical Chemistry Toxicities | Grade 1 | 5 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Clinical Chemistry Toxicities | Grade 2 | 9 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Clinical Chemistry Toxicities | Grade 3 | 3 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Clinical Chemistry Toxicities | Grade 4 | 1 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Clinical Chemistry Toxicities | Grade 4 | 1 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Clinical Chemistry Toxicities | Grade 1 | 5 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Clinical Chemistry Toxicities | Grade 3 | 7 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Clinical Chemistry Toxicities | Grade 2 | 14 Participants |
Other Pre-specified
Number of Participants With Hematology Toxicities
Blood samples were collected for the analysis of all hematology parameters. Laboratory toxicities were graded using the DAIDS Table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 hematology toxicities is presented.
Time frame: Day 1 and up to Week 684
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Hematology Toxicities | Grade 1 | 6 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Hematology Toxicities | Grade 2 | 5 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Hematology Toxicities | Grade 3 | 3 Participants |
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Hematology Toxicities | Grade 4 | 0 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Hematology Toxicities | Grade 4 | 2 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Hematology Toxicities | Grade 1 | 6 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Hematology Toxicities | Grade 3 | 2 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Hematology Toxicities | Grade 2 | 6 Participants |
Other Pre-specified
Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Day 1 and up to week 684
Population: Safety population included participants receiving FPV or FPV/RTV at any dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Treatment Emergent Adverse Events (AEs) | 25 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Treatment Emergent Adverse Events (AEs) | 29 Participants |
Other Pre-specified
Number of Participants With Treatment Limiting Toxicities
Treatment limiting toxicities are defined as those that are related to investigational medicinal products and deemed to be unacceptable, leading to restriction of further dose escalation.
Time frame: Day 1 and up to Week 684
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FPV/RTV BID: 4 Weeks to <6 Months | Number of Participants With Treatment Limiting Toxicities | 0 Participants |
| FPV/RTV BID: 6 Months to <2 Years | Number of Participants With Treatment Limiting Toxicities | 0 Participants |