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A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients

This study has been completed.
Study NCT00002168.   Last updated on October 1, 2007.   Information provided by Bristol-Myers Squibb

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Descriptive Information Fields
Brief Title  A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients
Official Title  An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
Brief Summary

The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.

Detailed Description

100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).

Patients will be treated for 48 weeks.

Study Phase
Study Type  Interventional
Study Design  Treatment, Parallel Assignment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Stavudine
Drug: Zidovudine
Drug: Didanosine
MEDLINE PMIDs
Links BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  200
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4 cell count of 200 - 700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

AIDS defining condition within 1 month of study entry.

Prior Medication:

Excluded:

Patients with any history of antiretroviral therapy treatment.

Gender Both
Ages 16 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Puerto Rico
Administrative Information Fields
NCT ID  NCT00002168
Organization ID 260B
Secondary IDs †† BMS 002
Study Sponsor  Bristol-Myers Squibb
Collaborators ††
Investigators 
Information Provided By Bristol-Myers Squibb
Verification Date October 2007
First Received Date  November 2, 1999
Last Updated Date October 1, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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