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A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002236
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
An Open-Label, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals
The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.
Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.
Interventional
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Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Delavirdine mesylate
  • 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
32
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Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
  • Have a CD4 cell count of at least 50 cells/mm3.
  • Are at least 14 years old (consent of parent or guardian is required if under 18).

Exclusion Criteria

You will not be eligible for this study if you:

  • Have ever taken an anti-HIV drug other than ZDV.
  • Have taken ZDV for more than 1 month.
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002236
228G
M/3331/0072
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Pharmacia and Upjohn
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NIH AIDS Clinical Trials Information Service
April 2000

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