A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

October 1, 2007 updated by: Bristol-Myers Squibb

An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml

To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Patients will be treated for 48 weeks.

Study Type

Interventional

Enrollment

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00731
        • Hosp Regional de Ponce - Area Vieja
      • Santurce, Puerto Rico, 00908
        • San Juan AIDS Program
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • HIV Clinical Research Ctr
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Advance Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State Univ Med Ctr / HIV Outpatient Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Univ Med Ctr Hosp / Evans - 556
      • Brookline, Massachusetts, United States, 02445
        • Community Research Initiative of New England
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Washington Univ School of Medicine
    • Texas
      • Austin, Texas, United States, 76751
        • Blackstock Family Health Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

October 2, 2007

Last Update Submitted That Met QC Criteria

October 1, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260A
  • BMS 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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