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A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00004583
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009

November 2, 1999
February 19, 2009
March 1999
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Complete list of historical versions of study NCT00004583 on ClinicalTrials.gov Archive Site
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A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects

The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.

Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Lopinavir/Ritonavir
  • Drug: Nelfinavir mesylate
  • Drug: Lamivudine
  • Drug: Stavudine
Not Provided
Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
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Inclusion Criteria

You may be eligible for this trial if you:

  • Are HIV positive.
  • Have a viral load (level of HIV in your blood) of more than 400 copies/ml.
  • Are age 12 or older.
  • Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this trial if you:

  • Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC.
  • Are seriously ill or have an AIDS-related infection.
  • Are pregnant or breast-feeding.
  • Are taking certain medications.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Brazil,   Canada,   Denmark,   France,   Germany,   Poland,   Puerto Rico,   South Africa,   Spain,   Switzerland,   United Kingdom
 
NCT00004583
285C, M98-863
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Abbott
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Abbott
February 2009

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