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

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. Identifier: NCT00002307
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : August 5, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Stavudine Drug: Zidovudine Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Actual Study Completion Date : December 1994

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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:


  • 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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002307

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

Additional Information:
Publications: Identifier: NCT00002307     History of Changes
Other Study ID Numbers: 116A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: August 2011

Keywords provided by Bristol-Myers Squibb:

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents