A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002410
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002410 on ClinicalTrials.gov Archive Site
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A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients
A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients

The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.

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Interventional
Phase 3
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Lamivudine
  • Drug: Zidovudine
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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
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Exclusion Criteria

Concurrent Medication:

Excluded:

  • Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]).
  • Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
  • Ketoconazole, itraconazole, and clarithromycin.
  • Concomitant systemic therapy for acute opportunistic infection or malignancy.

Excluded:

Life expectancy less than 12 months.

Prior Medication:

Excluded:

  • Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
  • Prior antiretroviral agent within 14 days of initiating study treatment.
  • Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.

Patients must:

  • Have a diagnosis of HIV infection.
  • Have CD4 counts greater than or equal to 50 cell/mm3.
  • Have a life expectancy greater than or equal to 12 months.
  • Be post-pubescent.
Both
13 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00002410
281B, DMP 266-006
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Dupont Merck
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NIH AIDS Clinical Trials Information Service
November 1998

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