The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients
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.
|HIV Infections||Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine Drug: Didanosine||Phase 4|
|Study Design:||Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Clinical Study to Determine If the Addition of HIV RNA Viral Load Is an Effective Tool in Determining Treatment Regimens for HIV-Infected Patients|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002376
|United States, California|
|Kaiser Foundation Hospital|
|San Francisco, California, United States, 94118|