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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

IL-12 has a number of effects in vitro that could be relevant to HIV disease including promotion of TH1 cell development, enhancement of HIV-specific T cell responses in cells from subjects with AIDS, and, of particular relevance to MAC disease, increasing secretion of cytotoxic cytokines such as IFN-gamma from both T lymphocytes and NK cells.

Part A (36 patients with less than 50 CD4+ cells/mm3):

Patients are randomized within one of three sequential dose cohorts and receive either rhIL-12 or matching placebo by subcutaneous injection twice weekly for four weeks. Eligible patients will p...

Gender

ALL

Eligibility 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.

Trial Officials