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

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002376

Run by

Merck Sharp & Dohme LLC

People needed

540

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have the following:
• CD4 count >= 300 and <= 750 cells/mm3.

You may not qualify if…

• Prior Medication:
• Excluded:
• Prior protease inhibitor therapy.

Where it is running

• Kaiser Foundation Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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