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
NCT ID: NCT00001116
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2000-06-30
Brief Summary
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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.
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Tumor Necrosis Factor soluble receptor-immunoadhesin complex
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Sha B
Role: STUDY_CHAIR
Valdez H
Role: STUDY_CHAIR
Landay A
Role: STUDY_CHAIR
Lederman M
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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Lange CG, Valdez H, Medvik K, Asaad R, Lederman MM. CD4+ T-lymphocyte nadir and the effect of highly active antiretroviral therapy on phenotypic and functional immune restoration in HIV-1 infection. Clin Immunol. 2002 Feb;102(2):154-61. doi: 10.1006/clim.2001.5164.
Sha B, Valdez H, Landay A, Gelman R, Namkung A, Agosti J, Bancroft L, Mildvan D, Mitsuyasu R, Pollard R, Ogata-Arakaki D, Kilgo P, Estep S, Fox L, Lederman M. Effect of recombinant human soluble tumor necrosis factor receptor (TNFR, etanercept) on interleukin-6 (IL- 6), TNF-a, and markers of immune activation in HIV-infected subjects receiving interleukin-2 (IL-2). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 66)
Sha BE, Valdez H, Gelman RS, Landay AL, Agosti J, Mitsuyasu R, Pollard RB, Mildvan D, Namkung A, Ogata-Arakaki DM, Fox L, Estep S, Erice A, Kilgo P, Walker RE, Bancroft L, Lederman MM. Effect of etanercept (Enbrel) on interleukin 6, tumor necrosis factor alpha, and markers of immune activation in HIV-infected subjects receiving interleukin 2. AIDS Res Hum Retroviruses. 2002 Jun 10;18(9):661-5. doi: 10.1089/088922202760019365.
Other Identifiers
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11498
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 928
Identifier Type: -
Identifier Source: org_study_id