A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
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
2 other identifiers
interventional
N/A
2 countries
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
45 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
December 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedAugust 5, 2011
August 1, 2011
November 2, 1999
August 4, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724, United States
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027, United States
Combat Group
Los Angeles, California, 90028, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento, California, 95817, United States
Children's Hosp of San Francisco
San Francisco, California, 94118, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308, United States
Univ of Miami
Miami, Florida, 331016960, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
Dr Steven Marlowe
Atlanta, Georgia, 30327, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Univ of Kansas School of Medicine / Univ Hosp
Kansas City, Kansas, 661607354, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124, United States
Chase Braxton Health Service
Baltimore, Maryland, 21201, United States
New England Deaconess Hosp
Boston, Massachusetts, 02215, United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985130, United States
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, 87131, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019, United States
Cornell Univ Med College
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153, United States
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468, United States
Nalle Clinic
Charlotte, North Carolina, 28207, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Montefiore Hosp
Pittsburgh, Pennsylvania, 15213, United States
Med Univ of South Carolina
Charleston, South Carolina, 29425, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Dr Edward Stool
Houston, Texas, 77004, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 782847881, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226, United States
UPR School of Medicine / San Juan Veterans Adm Med Ctr
San Juan, 009275800, Puerto Rico
Related Publications (1)
Spruance SL, Pavia AT, Mellors JW, Murphy R, Gathe J Jr, Stool E, Jemsek JG, Dellamonica P, Cross A, Dunkle L. Clinical efficacy of monotherapy with stavudine compared with zidovudine in HIV-infected, zidovudine-experienced patients. A randomized, double-blind, controlled trial. Bristol-Myers Squibb Stavudine/019 Study Group. Ann Intern Med. 1997 Mar 1;126(5):355-63. doi: 10.7326/0003-4819-126-5-199703010-00003.
PMID: 9054279BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
December 1, 1994
Last Updated
August 5, 2011
Record last verified: 2011-08