NCT00005106

A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (planned)
• Sponsor: Glaxo Wellcome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.

Detailed description

Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Lamivudine/Zidovudine
DRUG	Abacavir sulfate
DRUG	Nelfinavir mesylate
DRUG	Lamivudine
DRUG	Stavudine

Timeline

• Start date: 1999-09-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

39 sites across 1 country: United States