A Comparison of Zidovudine (AZT) and Stavudine in HIV-Infected Patients
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Zidovudine, Stavudine
Eligibility 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.
Sites / Locations
- Univ of Arizona / Health Science Ctr
- East Bay AIDS Ctr
- Children's Hosp of Los Angeles
- Combat Group
- Los Angeles County - USC Med Ctr
- Cedars Sinai Med Ctr
- UCD Med Ctr / AIDS and Related Disorders Clinic
- Children's Hosp of San Francisco
- Harbor UCLA Med Ctr
- Univ of Colorado Health Sciences Ctr
- Whitman - Walker Clinic
- George Washington Univ Med Ctr
- Community Research Initiative of South Florida
- TheraFirst Med Ctrs Inc
- Univ of Miami
- Infectious Disease Research Institute Inc
- Dr Steven Marlowe
- Northwestern Univ Med School
- Rush Presbyterian - Saint Luke's Med Ctr
- Infectious Diseases Research Clinic / Indiana Univ Hosp
- Univ of Kansas School of Medicine / Univ Hosp
- Univ of Kansas School of Medicine
- Chase Braxton Health Service
- New England Deaconess Hosp
- Univ of Nebraska Med Ctr / HIV Clinic
- Univ of New Mexico School of Medicine
- Bronx Veterans Affairs Med Ctr
- Beth Israel Med Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Cornell Univ Med College
- Mount Sinai Med Ctr
- SUNY / Health Sciences Ctr at Stony Brook
- Nalle Clinic
- Duke Univ Med Ctr
- Univ of Pennsylvania / HIV Clinic
- Buckley Braffman Stern Med Associates
- Montefiore Hosp
- Med Univ of South Carolina
- Univ of Texas Southwestern Med Ctr of Dallas
- Dr Edward Stool
- Houston Clinical Research Network
- Univ TX San Antonio Health Science Ctr
- Univ of Utah School of Medicine
- Milwaukee County Med Complex
- UPR School of Medicine / San Juan Veterans Adm Med Ctr