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Dose Optimisation of Stavudine for the Treatment of HIV Infection

NCT02670772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1077

Last updated 2016-02-02

No results posted yet for this study

Summary

The purpose of this study is to demonstrate whether low dose stavudine (d4T) is non-inferior (in terms of both viral suppression and toxicity) to tenofovir (TDF) after 2 years of HIV treatment.

Conditions

  • Acquired Immune Deficiency Syndrome
  • Human Immunodeficiency Virus

Interventions

DRUG

Stavudine

Stavudine 20mg twice daily for 96 weeks + Placebo 300mg once daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks

DRUG

Tenofovir Disoproxil Fumarate

TDF 300mg once daily + Placebo 20mg twice daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Willem Daniel Francois Venter

    lead OTHER

Principal Investigators

  • Francois Venter, FCP (SA) · Wits Reproductive Health & HIV Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • India
  • South Africa
  • Uganda

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 NCT02670772 on ClinicalTrials.gov