- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002376
The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- No antiretroviral therapy.
- 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.
- 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 Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94118
- Kaiser Foundation Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have the following:
CD4 count >= 300 and <= 750 cells/mm3.
Exclusion Criteria
Prior Medication:
Excluded:
Prior protease inhibitor therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Lamivudine
- Zidovudine
- Stavudine
- Indinavir
- Didanosine
Other Study ID Numbers
- 246F
- MK-0639
- 056-00
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