Active, not recruiting

Study Description:

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.

Viiv Study ID:

APV20002


Has Results Document Available
Clinicaltrials.gov Identifier:

NCT00071760


Has Results Available Below
EudraCT Number:

Not Available


Study Overview

Medical Conditions

Human Immunodeficiency Virus (HIV)

Product

abacavir;fosamprenavir;lamivudine;ritonavir

Collaborators

GSK


Date

October 2003 to June 2021

Type

Interventional

Phase

2


Gender

Both

Age

4 weeks - 2 years

Accepts Healthy Volunteers

No


Study Documents

This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Argentina, Buenos Aires, Buenos Aires 1405Completed
Mexico, Mexico 6720Completed
Mexico, Mexico, D.F. 06720Completed
Portugal, Almada 2805-267Completed
Portugal, Amadora 2700Terminated
Portugal, Lisboa 1649-035Completed
Puerto Rico, Puerto Rico, San Juan 00935Terminated
Russia, Moscow 105275Terminated
Russia, Moscow 129110Terminated
Russia, St. Petersburg 196645Terminated
South Africa, Soweto 2013Completed
South Africa, Soweto 2013Recruiting
South Africa, KwaZulu- Natal, Durban 4013Terminated
South Africa, Western Province, Parow Valley 7505Recruiting
United States, Florida, Jacksonville 32209Terminated
United States, North Carolina, Durham 27705Terminated

Study Design

  • Primary Purpose: Treatment
  • Allocation: Non-randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Plasma amprenavir (APV) AUC (0-tau[τ])
    Timeframe: Week 48

  • Plasma APV Cmax
    Timeframe: Week 48

  • Plasma APV Cτ
    Timeframe: Week 48

  • Plasma APV CL/F following dosing expressed in mL/min/kg
    Timeframe: Week 48

  • Plasma APV CL/F following dosing expressed in mL/min
    Timeframe: Week 48

  • Plasma unbound APV Cτ
    Timeframe: Week 48

  • Plasma unbound APV percent protein binding (%Cτ)
    Timeframe: Week 48

  • Median change from Baseline in alanine amino transferase (ALT) and aspartate amino transferase (AST) at Weeks 4, 12, 24, 36, and 48
    Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48

  • Median change from Baseline in cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglyceride (TG), potassium, and sodium at Weeks 4, 12, 24, 36, and 48
    Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48

  • Median change from Baseline in serum lipase at Weeks 4, 12, 24, and 48
    Timeframe: Baseline (Day 1) and Weeks 4, 12, 24, and 48

  • Number of participants with the indicated treatment-emergent (TE) Grade 3/4 laboratory abnormalities
    Timeframe: Baseline (Day 1) until Week 48

  • Number of participants with the indicated treatment-emergent (TE) Grade 3/4 adverse events (AE)
    Timeframe: Baseline (Day 1) until Week 48

  • Number of participants who permanently discontinued the treatment due to an AE
    Timeframe: Baseline (Day 1) until Week 48

Secondary Outcomes:

  • 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)
    Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

  • Median plasma HIV-1 RNA (log10 copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed analysis)
    Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

  • Median change from Baseline in plasma HIV-1 RNA (log10 copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed analysis)
    Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

  • 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)
    Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

  • Median percent cluster of differentiation antigen 4 (CD4+) cell count at Baseline and at Weeks 4, 12, 24, 36, and 48
    Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

  • Median percent change from Baseline in CD4+ cell count at Weeks 4, 12, 24, 36, and 48
    Timeframe: Baseline and Weeks 4, 12, 24, 36, and 48

  • Number of participants with the indicated virological outcome at Week 48
    Timeframe: Week 48

  • Plasma ritonavir (RTV) AUC (0-τ)
    Timeframe: Week 48

  • Plasma RTV Cmax
    Timeframe: Week 48

  • Plasma RTV Cτ
    Timeframe: Week 48

  • Plasma RTV CL/F expressed in mL/min/kg
    Timeframe: Week 48

  • Plasma RTV CL/F expressed in mL/min
    Timeframe: Week 48

  • Number of Confirmed Virologic Failure Participants (par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease
    Timeframe: Baseline through Week 48

  • Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)
    Timeframe: Baseline through Week 48

  • Number of participants reporting perfect adherence over the 3 days and last weekend prior to the study visits at Weeks 2, 12, 24, and 48 as assessed by the study coordinator using the Adherence Questionnaire
    Timeframe: Weeks 2, 12, 24, and 48

  • Number of participants with the indicated response scores for the Parent/Guardian (P/G) Perception of FPV oral suspension questionnaire: Items 1 to 4
    Timeframe: Weeks 2, 24, and 48/premature study discontinuation

  • 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
    Timeframe: Weeks (W) 2, 24, and 48/premature study discontinuation

  • 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
    Timeframe: Week 48

  • Plasma FPV AUC (0-τ)
    Timeframe: Week 48

  • Plasma FPV Cmax and Cτ
    Timeframe: Week 48

  • Plasma FPV CL/F expressed in mL/min/kg
    Timeframe: Week 48

  • Plasma FPV CL/F expressed in mL/min
    Timeframe: Week 48

Arms:
  • 2

Interventions:

  • Drug: GW433908
  • Drug: ritonavir

Keyword:

  • pediatrics, ritonavir, amprenavir, AGENERASE, HIV, Lexiva, protease inhibitors, HIV Infection, fosamprenavir
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 75

Clinical Publications:

  • Cotton M, Cassim H, Pavía-Ruz N, et al. Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV infected infants and children 4 week to 2 years of age – 48-week study data. Pediatr Infect Dis J.