A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002430
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 2000

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002430 on ClinicalTrials.gov Archive Site
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A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals

The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Nelfinavir mesylate
  • Drug: Lamivudine
  • Drug: Stavudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
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Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV positive.
  • Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
  • Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
  • Have a normal chest X-ray.
  • Have never taken protease inhibitors or 3TC.
  • Are 16 years of age or older.
  • Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).

Exclusion Criteria

You will not be eligible for this study if you:

  • Have an active opportunistic (AIDS-related) infection or cancer.
  • Have certain types of Kaposi's sarcoma.
  • Have hepatitis.
  • Have chronic diarrhea.
  • Have a history of certain medical conditions.
  • Are allergic to any of the study medications.
  • Are taking certain medications.
  • Are pregnant or breast-feeding.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002430
246R, 079-02, CRX454
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Merck Sharp & Dohme Corp.
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NIH AIDS Clinical Trials Information Service
February 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP