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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine if TNFR:Fc (a molecule that attaches to TNF) can lower the amount of IL-6 in HIV-positive patients. This study will also examine the effect of TNFR:Fc on TNF-alpha. IL-6 and TNF-alpha are 2 substances produced by the immune system that may increase the rate of HIV replication. IL-6 and TNF-alpha are produced naturally by the body. High levels of TNF-alpha lead to increased IL-6 production and increased HIV replication, therefore helping the virus infect the body. HIV-positive patients who receive IL-2 (interleukin-2, a protein that helps the immune system fight infection) tend to have higher levels of IL-6 and TNF-alpha than patients not receiving IL-2. These increased levels may contribute to some of the flu-like symptoms related to IL-2 administration. TNFR:Fc can neutralize TNF-alpha to decrease the action of TNF-alpha and, in turn, decrease the amount of IL-6 in the body. TNFR:Fc may, therefore, have a role in the treatment of HIV disease or in relieving some of the symptoms related to IL-2 administration.

Key facts

Study ID

NCT00001116

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

18

Expected to finish

2000-06-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Case CRS — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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