NCT00008554

Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy

A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.

Detailed description

Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Abacavir sulfate
DRUG	Nelfinavir mesylate
DRUG	Lamivudine
DRUG	GW433908

Timeline

• Start date: 2000-11-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

23 sites across 1 country: United States