A Study to Evaluate the Ability of TNFR:Fc to Decrease the Amount of IL-6 (Interleukin-6) and TNF-alpha (Tumor Necrosis Factor) in HIV-Infected Patients
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of July 15, 2025
Completed
Keywords
ClinConnect Summary
Both Interleukin-6 (IL-6) and Tumor necrosis factor-alpha (TNF-alpha) are substances naturally produced by the body's immune system. Evidence suggests that TNF-alpha production may be excessive or inappropriate in HIV-infected patients. Elevated TNF-alpha levels can result in increased IL-6 production and possibly increased HIV replication. TNFR:Fc is a modification of a natural substance that binds to TNF-alpha and neutralizes its activity. It is postulated that TNFR:Fc may result in decreased activity of TNF-alpha and lower IL-6 levels. HIV-infected patients who receive Interleukin-2 (IL-...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- You may be eligible for this study if you:
- • Are HIV-positive.
- • Are enrolled in ACTG 328.
- • Agree to practice abstinence or use barrier methods of birth control during the study.
- • Are at least 18 years old.
- • Exclusion Criteria
- You will not be eligible for this study if you:
- • Have any active opportunistic (HIV-associated) infections.
- • Have any medical condition or psychological issue that would interfere with study requirements.
- • Are pregnant or breast-feeding.
- • Are receiving any experimental drug other than IL-2.
- • Are receiving certain other medications.
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
Honolulu, Hawaii, United States
New York, New York, United States
Cleveland, Ohio, United States
Patients applied
Trial Officials
Sha B
Study Chair
Valdez H
Study Chair
Landay A
Study Chair
Lederman M
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials