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

• ClinicalTrials.gov Identifier: NCT00002376
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by: NIH AIDS Clinical Trials Information Service

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Indinavir sulfate; Drug: Lamivudine; Drug: Stavudine; Drug: Zidovudine; Drug: Didanosine	Phase 4

Detailed Description:

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.

Approximately 540 patients are stratified on the basis of baseline CD4 counts and are randomized to one of two treatment groups: 1. viral RNA treatment group or 2. non viral RNA treatment group. Treatment modification is based upon CD4 count, viral RNA levels (group 1 only) and clinical evaluation. Patients receive one of the three antiretroviral treatments:

1. No antiretroviral therapy.
2. Double reverse transcriptase inhibitor (RTI) therapy consisting of any two therapy combinations of: didanosine (ddI), lamivudine (3TC), stavudine (d4T) or zidovudine (ZDV), based upon the treating physician's judgment. The preferred combinations are ZDV + 3TC, d4T + 3TC or ddI + d4T.
3. Triple antiretroviral therapy consisting of double antiretroviral therapy plus indinavir.

Treatment decisions are based upon a standardized algorithm as follows:

CD4 count 500-750 + viral RNA < 10,000:

Group 1: No retroviral therapy. Group 2: No retroviral therapy.

CD4 count 500-750 + viral RNA >= 10,000:

Group 1: Triple therapy. Group 2: No retroviral therapy.

CD4 count 300-499 + viral RNA < 10,000:

Group 1: Double retroviral therapy. Group 2: Double retroviral therapy.

CD4 count 300-499 + viral RNA >= 10,000:

Group 1: Triple therapy. Group 2: Double retroviral therapy.

CD4 count 200-299 + viral RNA < 10,000:

Group 1: Maintain same retroviral therapy unless: there is a CD4 count decrease of 25-49% within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed, there is a CD4 count decrease of >= 50% within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated, or there is an AIDS-defining illness in which case triple therapy is initiated.

Group 2: Same as Group 1.

CD4 count 200-299 + viral RNA >= 10,000:

Group 1: Triple therapy. Group 2: Maintain same retroviral therapy unless: there is a CD4 count decrease of 25-49% within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed, there is a CD4 count decrease of >= 50% within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated, or there is an AIDS-defining illness in which case triple therapy is initiated.

CD4 count < 200:

Group 1: Triple therapy. Group 2: Triple therapy.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 540 participants
• 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

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

Patients must have the following:

CD4 count >= 300 and <= 750 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

Prior protease inhibitor therapy.

Contacts and Locations

Locations

United States, California

Kaiser Foundation Hospital

San Francisco, California, United States, 94118

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

More Information

• ClinicalTrials.gov Identifier: NCT00002376
• Other Study ID Numbers: 246F; MK-0639; 056-00
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Last Verified: June 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1; CD4 Lymphocyte Count; RNA, Viral; Anti-HIV Agents; Viral Load

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lamivudine; Zidovudine; Stavudine; Didanosine; Indinavir; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Antimetabolites; HIV Protease Inhibitors; Protease Inhibitors