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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-05-28

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

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

Truvada(FTC200mg+TDF300mg) every 24 hours + NVP 200 mg every 12 hours orally until week 72

DRUG

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

GPO-VIR S(D4T30mg+3TC150mg+NVP200mg)1 pill orally every 12 hours until week 24 and then switch to GPO-VIR Z

DRUG

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

GPO-VIR Z(AZT250mg+3TC150mg+NVP200mg) 1 pill orally every 12 hours until week 72

Sponsors & Collaborators

  • Queen Savang Vadhana Memorial Hospital, Thailand

    collaborator OTHER

  • Thai Red Cross AIDS Research Centre

    collaborator OTHER

  • University of Hawaii

    collaborator OTHER

  • SEARCH Research Foundation

    lead OTHER

Principal Investigators

  • Jintanat - Ananworanich, M.D. · SEARCH Thailand

  • Jintanat - Ananworanich, M.D., Ph.D · SEARCH Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-12-31
Completion
2011-04-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00669487 on ClinicalTrials.gov