At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 753 enrolled
Drug / intervention
fosamprenavir (GW433908) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects
In Brief
A Phase 3 clinical trial evaluating fosamprenavir (GW433908) and ritonavir for Infection, Human Immunodeficiency Virus. Completed, enrolled 753 participants across 24 sites in 8 countries.
Detailed Summary
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection, Human Immunodeficiency Virus
CountriesBrazil, Chile, France, Italy, Portugal, Spain, United Kingdom, United States
CollaboratorsGlaxoSmithKline
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2001
First PostedFeb 2006
Primary CompletionOct 2010
TodayJul 2026
First PostedFeb 27, 2006
Enrollment StartNov 1, 2001
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 20.3 years ago
Interventions
fosamprenavir (GW433908)drug
ritonavirdrug