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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


N/A
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

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


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).

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Principal Investigator

Sha B

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 928

NCT ID:

NCT00001116

Start Date:

Completion Date:

June 2000

Related Keywords:

  • HIV Infections
  • Tumor Necrosis Factor
  • Interleukin-2
  • Immunity, Cellular
  • Antiviral Agents
  • Interleukin-6
  • Receptors, Tumor Necrosis Factor
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Necrosis

Name

Location

Univ. of Hawaii at Manoa, Leahi Hosp.Honolulu, Hawaii  96816
NY Univ. HIV/AIDS CRSNew York, New York  10016
Case CRSCleveland, Ohio  44106