A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002401
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 NCT00002401 on ClinicalTrials.gov Archive Site
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A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals

The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).

In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:

Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.

  • Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.
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
160
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Inclusion Criteria

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

  • Prior indinavir.
  • Prior lamivudine.
  • Prior protease inhibitors.
  • Prior non-nucleoside reverse transcriptase inhibitors.
  • 1 month or more prior zidovudine.

    1. HIV-1 positive.

  • CD4 coun tis above 50.
  • HIV-1 RNA levels greater than 20,000.
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002401
228F, 0074
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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