A Study of CI-1012 in HIV-Infected Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Parke-Davis

Criteria

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.