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

NCT00669487 Phase 3 COMPLETED

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.

Details

Lead sponsor	SEARCH Research Foundation
Phase	Phase 3
Status	COMPLETED
Enrolment	150
Start date	2008-04
Completion	2011-04

Conditions

• HIV Infections

Interventions

• AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
• AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP
• AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP

Primary outcomes

• Change from baseline in mean hemoglobin at 24 weeks and 72 weeks — 72 weeks
• Proportion of participants with peripheral neuropathy at 24 weeks and 72 weeks — 72 weeks

Countries

Thailand