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Differences Between Stavudine and Tenofovir Each Combined With Lamivudine and Efavirenz in SA HIV-infected Patients

NCT01601899 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-05-18

No results posted yet for this study

Summary

Even with the benefits of HIV therapy, there is a possibility that HIV-infected individuals develop metabolic complications once they initiate treatment, which may also ultimately put them at a risk for impending heart disease in the next decades.

The main mechanism through which the main HIV drugs are thought to cause these metabolic changes and organ toxicities is mitochondrial toxicity. Most of studies that have been done, have taken place in the West, but few, if any, have been done in South Africa.

The purpose of this study is to prospectively identify early changes between the two different drugs, Stavudine and Tenofovir, to assess their virological response, molecular, biochemical and clinical picture, and the possible associated change in cardiovascular risk factors, this, in the South African setting, and make recommendations to modify the current National AIDS role out programme

Conditions

  • Mitochondrial Toxicity
  • Metabolic Complications

Interventions

DRUG

Stavudine

30 mg po BD if wt \< 60kg, or 40 mg po BD if wt \> 60kg

DRUG

Stavudine

20 mg po BD if wt \< 60kg, or 30 mg po BD if wt \> 60kg

DRUG

Tenofovir

300 mg po QD

Sponsors & Collaborators

  • University of Witwatersrand, South Africa

    lead OTHER

Principal Investigators

  • Colin N Menezes, FCP(SA) · Clinical HIV Research Unit, University of the Witwatersrand

  • Ian Sanne, FCP(SA) · Clinical HIV Research Unit, University of the Witwatersrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • South Africa

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 NCT01601899 on ClinicalTrials.gov