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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
History of Changes
  Purpose

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.


Condition Intervention
HIV Infections
 Drug: Indinavir sulfate
Drug: Nelfinavir mesylate
Drug: Lamivudine
Drug: Stavudine

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 220
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002430

  Show 46 Study Locations
Sponsors and Collaborators
Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002430     History of Changes
Other Study ID Numbers: 246R, 079-02, CRX454
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Lamivudine
Indinavir
 Reverse Transcriptase Inhibitors
Anti-HIV Agents
Nelfinavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Indinavir
Nelfinavir
 Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013