At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 110 enrolled
Drug / intervention
LEXIVA (GW433908) +1 moredrug
Likely dose
Fosamprenavir (Lexiva) suspension or tablet twice daily with ritonavir twice dailyAI-extracted
Key inclusion· 4
- ✓Age 2 to <6 years (Cohort 2), 2 to <12 years (Cohort 3), or 2 to <19 years (Cohort 1A/1B)
- ✓Screening plasma HIV-1 RNA ≥400 copies/mL
- ✓PI-naïve (no PI or <1 week prior PI) or PI-experienced (>1 week prior PI with no more than three PIs)
- ✓Able to comply with study requirements and provide informed consent (parent/legal guardian)
Key exclusion· 8
- ✕Prior fosamprenavir or APV for >7 days
- ✕NNRTI use within 14 days prior to study drug or anticipated concurrent NNRTI use
- ✕Malabsorption syndrome or gastrointestinal dysfunction that could impair drug absorption or ability to take oral medication
- ✕Grade 3 or 4 transaminase elevation (ALT and/or AST) within 28 days or clinically relevant hepatitis within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 48 Week, Phase II, Non-Comparative, Open-label, Multi-Cohort, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir BID When Administered to HIV-1 Infected, PI-Naïve and Experienced, Pediatric Subjects, 2 to 18 Years Old and of GW433908 BID Administered to PI-Naïve, Pediatric Subjects 2 to < 6 Years Old
In Brief
A Phase 2 clinical trial evaluating LEXIVA (GW433908) and Ritonavir for Infection, Human Immunodeficiency Virus I. Completed, enrolled 110 participants across 39 sites in 7 countries.
Detailed Summary
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, Romania, Russia, South Africa, Spain, United States
CollaboratorsGlaxoSmithKline
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
First PostedAug 2004
Primary CompletionMar 2011
Study CompletionJul 2013
TodayJul 2026
First PostedAug 10, 2004
Enrollment StartJul 1, 2004
Primary CompletionMar 1, 2011
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 21.9 years ago
Interventions
LEXIVA (GW433908)drug
Fosamprenavir suspension or tablet bid
Ritonavirdrug
Ritonavir solution bid