A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
NCT ID: NCT00002307
Last Updated: 2011-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
1994-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Stavudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States
East Bay AIDS Ctr
Berkeley, California, United States
Children's Hosp of Los Angeles
Los Angeles, California, United States
Combat Group
Los Angeles, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Cedars Sinai Med Ctr
Los Angeles, California, United States
UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento, California, United States
Children's Hosp of San Francisco
San Francisco, California, United States
Harbor UCLA Med Ctr
Torrance, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Community Research Initiative of South Florida
Coral Gables, Florida, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States
Univ of Miami
Miami, Florida, United States
Infectious Disease Research Institute Inc
Tampa, Florida, United States
Dr Steven Marlowe
Atlanta, Georgia, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States
Univ of Kansas School of Medicine / Univ Hosp
Kansas City, Kansas, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
Chase Braxton Health Service
Baltimore, Maryland, United States
New England Deaconess Hosp
Boston, Massachusetts, United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, United States
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, United States
Beth Israel Med Ctr
New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Cornell Univ Med College
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, United States
Bronx Veterans Affairs Med Ctr
The Bronx, New York, United States
Nalle Clinic
Charlotte, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Montefiore Hosp
Pittsburgh, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Dr Edward Stool
Houston, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States
UPR School of Medicine / San Juan Veterans Adm Med Ctr
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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AI455-019
Identifier Type: -
Identifier Source: secondary_id
116A
Identifier Type: -
Identifier Source: org_study_id
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