We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002430
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
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.
Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.
Interventional
Not Provided
Primary Purpose: Treatment
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Nelfinavir mesylate
  • Drug: Lamivudine
  • Drug: Stavudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
Not Provided
Not Provided

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV positive.
  • Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
  • Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
  • Have a normal chest X-ray.
  • Have never taken protease inhibitors or 3TC.
  • Are 16 years of age or older.
  • Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).

Exclusion Criteria

You will not be eligible for this study if you:

  • Have an active opportunistic (AIDS-related) infection or cancer.
  • Have certain types of Kaposi's sarcoma.
  • Have hepatitis.
  • Have chronic diarrhea.
  • Have a history of certain medical conditions.
  • Are allergic to any of the study medications.
  • Are taking certain medications.
  • Are pregnant or breast-feeding.
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002430
246R
079-02
CRX454
Not Provided
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
February 2000

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