CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
GW433908 +1 moredrug
Likely dose
Fosamprenavir suspension twice daily with ritonavir solution twice dailyAI-extracted
Key inclusion· 4
  • ✓Age 4 weeks to <2 years (Cohort 1: 6 months to <2 years; Cohort 2: 4 weeks to <6 months)
  • ✓Plasma HIV-1 RNA ≥400 copies/mL at screening
  • ✓Ability to construct an active 2-NRTI backbone regimen per investigator and viral resistance testing
  • ✓PI-naive (less than one week of any PI) or PI-experienced (no more than three PIs, with RTV-boosted PI counted as one)
Key exclusion· 9
  • ✕Prior exposure to amprenavir (APV)
  • ✕NNRTI therapy within 14 days prior to study drug administration or anticipated need during study
  • ✕PI therapy within 5 days prior to study drug administration (for single dose visits)
  • ✕Acute phase CDC Clinical Category C event at baseline, unless receiving treatment and clinically improving

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00071760
NCT00071760Phase 2Completed
CompareCT.gov

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.

ViiV Healthcare·interventional·Posted Oct 31, 2003·Updated Oct 10, 2023

In Brief

A Phase 2 clinical trial evaluating GW433908 and ritonavir for Infection, Human Immunodeficiency Virus and HIV Infections. Completed, enrolled 59 participants across 15 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Human Immunodeficiency Virus, HIV Infections
CountriesArgentina, Mexico, Portugal, Puerto Rico, Russia, South Africa, United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2003
Enrollment StartOct 23, 2003
Primary CompletionJul 5, 2011
Study CompletionMar 29, 2022
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 22.7 years ago

Interventions

GW433908drug

Fosamprenavir suspension bid

ritonavirdrug

Ritonavir solution bid