HIV Infections
Conditions
Keywords
Dose-Response Relationship, Drug, Administration, Oral, Drug Administration Schedule, CD4 Lymphocyte Count, Anti-HIV Agents
Brief summary
The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.
Detailed description
Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.
Interventions
DRUGCI-1012
Sponsors
Parke-Davis
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patients must have: * Serologic evidence of infection with HIV-1. * CD4+ cell count \>= 200 cells/mm3. * HIV-1 RNA \>= 10,000 copies/ml.
Exclusion criteria
Co-existing Condition: Patients with the following conditions are excluded: Viral, fungal, or bacterial infection requiring therapy other than topical medications. Concurrent Medication: Excluded: * Prophylactic systematic antibacterial, antifungal or antiviral agents. * Antiretroviral therapy. NOTE: * Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication. Prior Medication: Excluded: * Experimental therapy for \>= 4 weeks prior to initiation of study medication. * Antiretroviral treatment for 3 weeks prior to initiation of study medication. * Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.
Countries
United States
Outcome results
None listed