A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
Asymptomatic or mildly symptomatic.
CD4 count 100 - 300 cells/mm3.
Prior antiretroviral agents for up to 6 months per agent.
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.