drugset / Trial / NCT01601899

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

NCT01601899

Phase 4 Terminated 60 enrolled University of Witwatersrand, South Africa
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Stavudine Other / unclassified 20 mg Oral
Comparator Stavudine Other / unclassified 30 mg Oral
Comparator Stavudine Other / unclassified 40 mg Oral
Comparator Tenofovir Small molecule 300 mg Oral

Indications