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Home > "A" Clinical Trials Conditions > A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients  A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Med Univ of South Carolina
Charleston, South Carolina, 29425
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Kansas School of Medicine / Univ Hosp
Kansas City, Kansas, 661607354
United States
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724
United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
TheraFirst Med Ctrs Inc
Ft. Lauderdale, Florida, 33308
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Dr Edward Stool
Houston, Texas, 77004
United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985130
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Bronx Veterans Affairs Med Ctr
Bronx, New York, 10468
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027
United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Combat Group
Los Angeles, California, 90028
United States
Children's Hosp of San Francisco
San Francisco, California, 94118
United States
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
United States
Dr Steven Marlowe
Atlanta, Georgia, 30327
United States
Montefiore Hosp
Pittsburgh, Pennsylvania, 15213
United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 782847881
United States
New England Deaconess Hosp
Boston, Massachusetts, 02215
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento, California, 95817
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Univ of Miami
Miami, Florida, 331016960
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Nalle Clinic
Charlotte, North Carolina, 28207
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, 20009
United States
UPR School of Medicine / San Juan Veterans Adm Med Ctr
San Juan, , 009275800
Puerto Rico
Chase Braxton Health Service
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: 116A; AI455-019
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002307
Other Hiv Infections Studies:
1. HIV Symptom Management Program for African American Mothers
2. Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
3. Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
4. A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma
5. A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
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