CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
ritonavir +1 moredrug
Likely dose
Fosamprenavir/ritonavir dosing not explicitly stated in criteria; typical pediatric dosing by age/weight would applyAI-extracted
Key inclusion· 5
  • ✓Age 2 to 18 years
  • ✓HIV-1 RNA ≥400 copies/mL at screening
  • ✓Able to construct an active NRTI backbone regimen of 2 NRTIs
  • ✓Either ART-naive (less than 4 weeks NRTI, no NNRTI, less than 1 week PI) or ART-experienced (greater than 4 weeks NRTI with any NNRTI/PI history, maximum 3 prior PIs)
Key exclusion· 8
  • ✕Prior history of amprenavir use
  • ✕NNRTI therapy within 14 days of study Day 1 or anticipated concurrent NNRTI therapy
  • ✕AIDS-defining illness (acute CDC Category C event) within 28 days of screening
  • ✕Grade 3 or 4 transaminases (ALT/AST) within 28 days or clinically relevant hepatitis within 6 months

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

Search/NCT00040664
NCT00040664Phase 2Completed
CompareCT.gov

A 48 Week, Phase II, Open-Label Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir QD and GW433908/Ritonavir BID When Administered to HIV-1 Infected, Antiretroviral Naive and Experienced, Pediatric Subjects 2-18 Years Old

ViiV Healthcare·interventional·Posted Jul 10, 2002·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating ritonavir and fosamprenavir for HIV Infection. Completed, enrolled 69 participants across 42 sites in 7 countries.

Detailed Summary

This is a 48-week study to collect additional information on the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen (course of therapy) including FDA approved HIV drugs in HIV-infected patients 2 - 18 years old.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesCanada, Italy, Netherlands, Portugal, Romania, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 10, 2002
Enrollment StartJul 1, 2002
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 24.0 years ago

Interventions

ritonavirdrug

ritonavir oral capsules or oral solution

fosamprenavirdrug

fosamprenavir oral suspension or tablet