A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
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To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Prior antiretroviral agents for up to 6 months per agent.
Patients must have:
Asymptomatic or mildly symptomatic.
CD4 count 301 - 500 cells/mm3.
Patients with the following condition are excluded:
Unable or unwilling to comply with study procedures.
Chemoprophylactic therapy for mycobacterial infection.
Any nonstudy prescription medications without approval of investigator.
Patients with the following prior conditions are excluded:
History of grade 3 or 4 toxicity to <= 600 mg/day AZT.
History of intolerance to lactose.
Chronic diarrhea within 6 months prior to study entry.
Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry.
Antiretroviral therapy within 2 weeks prior to study entry.
Prior HIV vaccines.
Biological response modifiers within 30 days prior to study entry.
Any investigational drug with a washout < 5 half-lives prior to study entry.
Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.