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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Tumor Necrosis Factor soluble receptor-immunoadhesin complex |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | Effect of Recombinant Human Soluble Tumor Necrosis Factor Receptor (TNFR:Fc) on Interleukin-6 (IL-6), Tumor Necrosis Factor-Alpha (TNF-alpha) and Markers of Immune Activation in HIV-Infected Subjects |
| Estimated Enrollment: | 18 |
| Study Completion Date: | June 2000 |
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-2) have been shown to have higher TNF-alpha and IL-6 levels than those who do not receive IL-2. It is thought that these higher levels of TNF-alpha and IL-6 may contribute to some of the flu-like symptoms experienced by patients receiving IL-2. By decreasing the amount of IL-6 in the body and by decreasing the action of TNF-alpha in the body, TNFR:Fc may have a role in the treatment of HIV disease or in alleviating some of the symptoms related to IL-2 administration.
Six patients from each of the 3 treatment arms of ACTG 328 (HAART alone, HAART plus intravenous (IV) rhIL-2, and HAART plus subcutaneous (SC) rhIL-2) who are about to be randomized to Step II of ACTG 328 may participate in this prospective, nested substudy. Patients randomized to the Interleukin-2 (IL-2) arms of ACTG 328 are pretreated with TNFR:Fc (administered by infusion over 30 minutes) at week 16 of ACTG 928 (Course 3, Week 28 of ACTG 328), just prior to initiation of IL-2. Those randomized to the highly active antiretroviral therapy (HAART) only arm of ACTG 328 receive treatment with TNFR:Fc at Week 16 of ACTG 928 (Week 28 of ACTG 328).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Hawaii | |
| Univ. of Hawaii at Manoa, Leahi Hosp. | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, New York | |
| NY Univ. HIV/AIDS CRS | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| Case CRS | |
| Cleveland, Ohio, United States, 44106 | |
| Study Chair: | Sha B | |
| Study Chair: | Valdez H | |
| Study Chair: | Landay A | |
| Study Chair: | Lederman M |
More Information
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001116 History of Changes |
| Other Study ID Numbers: | ACTG 928, 11498 |
| Study First Received: | November 2, 1999 |
| Last Updated: | May 21, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Tumor Necrosis Factor Interleukin-2 Immunity, Cellular |
Antiviral Agents Interleukin-6 Receptors, Tumor Necrosis Factor |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Necrosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on February 26, 2013
