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

This study has been completed.

Sponsored by: Merck
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002376
  Purpose

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 Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Drug: Didanosine
Phase IV

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine    Lamivudine    Indinavir    Indinavir Sulfate    Didanosine    Stavudine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Parallel Assignment
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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   540

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002376

Locations
United States, California
Kaiser Foundation Hospital    
      San Francisco, California, United States, 94118

Sponsors and Collaborators
Merck
  More Information


Study ID Numbers:   246F, MK-0639, 056-00
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002376
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1  
CD4 Lymphocyte Count  
RNA, Viral  
Anti-HIV Agents  
Viral Load  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Stavudine
Didanosine
Indinavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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