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
Trial Information
Current as of January 15, 2025
Completed
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
Mark Jacobson
Study Chair
Richard Pollard
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Francisco, California, United States
Torrance, California, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
Chicago, Illinois, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
Similar Trials