drugset / Trial / NCT00002376

The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients

NCT00002376

Phase 4 Completed 540 enrolled Merck Sharp & Dohme LLC
Parallel-groupTreatment

Summary

To evaluate, in HIV-infected patients whose baseline CD4 count is 300 to 750 cells/mm3, whether an antiretroviral treatment regimen based upon clinical evaluation and CD4 counts plus HIV RNA viral load is more effective than a treatment regimen based upon clinical evaluation and CD4 counts without the use of HIV RNA viral load information. To assess relative utility of viral load testing in determining therapeutic choice by the surrogate marker of CD4 cell counts after 48 weeks of therapy. It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range of 300 to 750 cells/mm3, those patients who incorporate initial and periodic viral RNA measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than patients whose therapeutic decisions do not incorporate initial and periodic viral RNA measurements.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Didanosine Small molecule
Subject INDINAVIR ANHYDROUS Other / unclassified
Subject Lamivudine Other / unclassified
Subject Stavudine Other / unclassified
Subject Zidovudine Small molecule