drugset / Trial / NCT00669487
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
Phase 3
Completed
150 enrolled
SEARCH Research Foundation
Queen Savang Vadhana Memorial Hospital, Thailand · collabThai Red Cross AIDS Research Centre · collabUniversity of Hawaii · collab
RandomizedFactorialOpen-labelTreatment
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.
Timeline
- Start
- 2008-04
- Primary completion
- 2010-12
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GPO-VIR S | Unknown | — | Oral |
| Subject | GPO-VIR Z | Unknown | — | Oral |
| Subject | Tenofovir | Small molecule | — | Oral |
| Background | NVP | Unknown | — | Oral |