A Study of Two 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:
NCT00002400
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002400 on ClinicalTrials.gov Archive Site
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A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients
An Open-Label Randomized Study of Delavirdine Mesylate (Rescriptor) in Combination With Zidovudine (Retrovir) and Two Doses of Indinavir (Crixivan) Versus Zidovudine, Lamivudine (Epivir), and Indinavir in HIV-1-Infected Individuals

The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.

In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.

Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Delavirdine mesylate
  • 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
45
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Inclusion Criteria

Patients must have:

  • HIV-1 positive.
  • CD4 count above 50.
  • HIV-1 RNA greater than 20,000.

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

  • Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors.
  • Prior ZDV of greater than 1 month total duration.

Prior Treatment:

Excluded:

  • Lamivudine.
  • Protease inhibitors.
  • Non-nucleoside reverse transcriptase inhibitors.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002400
228C, 0063
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Pharmacia and Upjohn
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NIH AIDS Clinical Trials Information Service
January 1999

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