A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients

August 4, 2011 updated by: Bristol-Myers Squibb

A Double-Blind Comparison of Zidovudine (AZT) Versus Stavudine (d4T; BMY 27857) for the Treatment of Patients With HIV Infection Who Have Absolute CD4 Lymphocyte Counts Between 50 and 500 Cells/mm3

To compare stavudine (d4T) and zidovudine (AZT) in slowing the progression of HIV disease. To compare the antiviral activity of d4T versus AZT as measured by plasma levels of p24 antigen and HIV viremia, and their relative efficacy by improvement and/or absence of adverse changes over time in laboratory parameters associated with HIV infection. To compare the safety of oral doses of d4T to AZT in patients with HIV infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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
      • San Juan, Puerto Rico, 009275800
        • UPR School of Medicine / San Juan Veterans Adm Med Ctr
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Univ of Arizona / Health Science Ctr
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Los Angeles, California, United States, 90027
        • Children's Hosp of Los Angeles
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Med Ctr
      • Los Angeles, California, United States, 90028
        • Combat Group
      • Sacramento, California, United States, 95817
        • UCD Med Ctr / AIDS and Related Disorders Clinic
      • San Francisco, California, United States, 94118
        • Children's Hosp of San Francisco
      • Torrance, California, United States, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 20009
        • Whitman - Walker Clinic
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Community Research Initiative of South Florida
      • Fort Lauderdale, Florida, United States, 33308
        • TheraFirst Med Ctrs Inc
      • Miami, Florida, United States, 331016960
        • Univ of Miami
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Dr Steven Marlowe
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Infectious Diseases Research Clinic / Indiana Univ Hosp
    • Kansas
      • Kansas City, Kansas, United States, 661607354
        • Univ of Kansas School of Medicine / Univ Hosp
      • Wichita, Kansas, United States, 672143124
        • Univ of Kansas School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Chase Braxton Health Service
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • New England Deaconess Hosp
    • Nebraska
      • Omaha, Nebraska, United States, 681985130
        • Univ of Nebraska Med Ctr / HIV Clinic
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Univ of New Mexico School of Medicine
    • New York
      • Bronx, New York, United States, 10468
        • Bronx Veterans Affairs Med Ctr
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10021
        • Cornell Univ Med College
      • New York, New York, United States, 10019
        • Saint Luke's - Roosevelt Hosp Ctr
      • Stony Brook, New York, United States, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania / HIV Clinic
      • Pittsburgh, Pennsylvania, United States, 15213
        • Montefiore Hosp
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Med Univ of South Carolina
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Houston, Texas, United States, 77006
        • Houston Clinical Research Network
      • Houston, Texas, United States, 77004
        • Dr Edward Stool
      • San Antonio, Texas, United States, 782847881
        • Univ TX San Antonio Health Science Ctr
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Univ of Utah School of Medicine
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Milwaukee County Med Complex

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

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • AZT.

Patients must have:

  • Documented HIV infection as determined by a positive ELISA and/or Western blot.
  • Absolute CD4 count of 100 - 500 cells/mm3 within 90 days prior to registration OR a CD4 count of 50 - 99 cells/mm3 within 30 days prior to registration.
  • Prior zidovudine therapy for at least 6 months and currently tolerating at least 500 mg daily.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at time of enrollment.
  • Need for chronic systemic therapy at time of enrollment.
  • Intractable diarrhea.
  • Signs or symptoms of bilateral peripheral neuropathy at time of screening.
  • Demonstrated intolerance to zidovudine therapy.
  • Any other clinical conditions that would render the patient unsuitable for study or unable to comply with the dosing requirements.

Concurrent Medication:

Excluded:

  • Chronic systemic therapy with agents likely to suppress bone marrow, cause neurotoxicity, or create hepatic dysfunction.

Patients with the following prior conditions are excluded:

  • Prior history of bilateral peripheral neuropathy.
  • Demonstrated intolerance to zidovudine therapy.

Prior Medication:

Excluded:

  • Prior d4T, ddI, or ddC.
  • Other investigational antiretroviral drugs (e.g., AZddU, Al 721, interferon, or immunomodulating drugs within 1 month prior to study entry or ribavirin within 3 months prior to study entry).
  • Prior myelosuppressive, neurotoxic, or cytotoxic anticancer therapy within 3 months prior to study entry.
  • Any prior therapy that would render the patient unsuitable for study or unable to comply with dosing requirements.

Required:

  • At least 6 months of prior AZT and currently tolerating at least 500 mg daily, with the last dose received no more than 7 days prior to study entry.

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
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Completion (Actual)

December 1, 1994

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)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116A
  • AI455-019

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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