A Study of CI-1012 in HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002196

Run by

Parke-Davis

People needed

32

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• Serologic evidence of infection with HIV-1.
• CD4+ cell count >= 200 cells/mm3.
• HIV-1 RNA >= 10,000 copies/ml.

You may not qualify if…

• 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.

Where it is running

• ViRx Inc — Palm Springs, California, United States
• ViRx Inc — San Francisco, California, United States
• Central Florida Research Initiative — Maitland, Florida, United States
• Natl Institutes of Health — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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