To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic HIV-infected patients. Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness.
Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness. Enrollment during the first 8 weeks of the study is restricted to hemophiliacs and sexual partners of hemophiliacs with asymptomatic HIV disease. After the initial 8 weeks this restriction is lifted. Patients are randomized to one of four treatment arms with dosing of AZT plus ddI or ddI alone.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, United States
Whitman - Walker Clinic
Washington D.C., District of Columbia, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States
Univ of Washington
Seattle, Washington, United States
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