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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002307
First received: November 2, 1999
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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 Intervention
HIV Infections
Drug: Stavudine
Drug: Zidovudine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Completion Date: December 1994
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002307

  Hide Study Locations
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
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
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
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
Cornell Univ Med College
New York, New York, United States, 10021
Mount Sinai Med Ctr
New York, New York, United States, 10029
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10019
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
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, United States, 19104
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
Houston Clinical Research Network
Houston, Texas, United States, 77006
Dr Edward Stool
Houston, Texas, United States, 77004
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
Investigators
Principal Investigator: . ., . .
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002307     History of Changes
Other Study ID Numbers: 116A, AI455-019
Study First Received: November 2, 1999
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Zidovudine
Stavudine

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

ClinicalTrials.gov processed this record on November 24, 2014