A Study to Evaluate the Effects of Interleukin-12 (rhIL-12) in HIV-Positive Patients With CD4 Cell Counts Less Than 50 Cells/mm3 or 300-500 Cells/mm3

• Status: Completed
• Trial end date: 2001-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the tolerance and effectiveness of rhIL-12 in HIV-positive patients with CD4 cell counts less than 50 cells/mm3 versus 300-500 cells/mm3. This study will look at the ability of rhIL-12 to boost the immune system against HIV and HIV-associated bacterial infections in these patients.

IL-12 is found naturally in the body and rhIL-12 is the commercially produced version. IL-12 may enhance anti-HIV immune system activity by increasing the number of cells that fight infection. IL-12 may also increase the body's ability to fight bacterial infections such as Mycobacterium avium complex (MAC).

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interleukin-12

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Are 18-60 years old.

• Have a CD4 count less than 50 cells/mm3 or between 300-500 cells/mm3 within 30 days of study entry.

• Are expected to live at least 12 weeks.

• Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have a history of cytomegalovirus (CMV) end-organ disease.

• Have a history of invasive fungal disease, unless the condition has been stable for 2 months.

• Have a history of severe allergic reactions to IL-2 or IL-12.

• Have a history of heart problems, autoimmune or rheumatologic disease, gastrointestinal bleeding, or any condition that would keep you from completing the study.

• Have MAC-related symptoms (fever, weight loss, frequent diarrhea) for at least 2 months prior to study entry.

• Are enrolled in another experimental research treatment study.

• Abuse alcohol or drugs.

• Are pregnant or breast-feeding.