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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00000857

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

65

Expected to finish

2001-06-01

Last updated by the study team

2021-10-29

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• USC CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Weiss Memorial Hosp. — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• University of Washington AIDS CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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