Overview

A 72-week Randomized Clinical Trial Comparing the Safety and Efficacy of Three Initial Antiretroviral Regimens -GPO-VIR S (d4T/3TC/NVP) for 24 Weeks Followed by GPO-VIR Z (AZT/3TC/NVP) vs GPO-VIR Z vs TDF/FTC/NVP

Status:
Completed

Trial end date:
2011-04-01

Target enrollment:

Participant gender:

Summary

This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function.

Phase:

Phase 3

Details

Lead Sponsor:

South East Asia Research Collaboration with Hawaii

Collaborators:

Queen Savang Vadhana Memorial Hospital, Thailand
Thai Red Cross AIDS Research Centre
University of Hawaii

Treatments:

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lamivudine
Stavudine