A Study of CI-1012 in HIV-Infected Patients

A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.

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.

Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.

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.