HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, MDL 28574
Brief summary
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.
Interventions
Sponsors
Hoechst Marion Roussel
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * HIV infection. * Asymptomatic or mildly symptomatic. * CD4 count 100 - 300 cells/mm3. Prior Medication: Allowed: * Prior antiretroviral agents for up to 6 months per agent.
Exclusion criteria
Co-existing Condition: Patients with the following condition are excluded: Unable or unwilling to comply with study procedures. Concurrent Medication: Excluded: * 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. Prior Medication: Excluded: * Antiretroviral therapy within 2 weeks prior to study entry. * Prior HIV vaccines. * Biological response modifiers within 30 days prior to study entry. * Prior foscarnet. * 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. Recent history of alcohol and/or drug abuse.
Countries
United States
Outcome results
None listed