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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001004 |
To study the tolerance and toxicity of the combination of tumor necrosis factor (TNF) and interferon gamma (IFN-G) or as single agent TNF or IFN-G in HIV infected patients. To selectively monitor the immune system of AIDS related complex (ARC) patients who receive either combination therapy or TNF or IFN-G alone. To obtain information on the effectiveness of combination therapy or TNF or IFN-G alone against HIV in ARC patients.
Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which causes AIDS and ARC in some laboratory studies, but may increase virus replication in other laboratory studies. Previous studies in humans showed no increase in virus cultures and some decrease in measurements of virus. Extensive preclinical data show that TNF and IFN-G are more effective together than separately in laboratory and animal studies. As single agents, both TNF and IFN-G have modest effect against HIV. Studies have demonstrated that TNF and IFN-G, in combination, can not only inhibit HIV infection of previously uninfected cells, but also can selectively induce the destruction of acutely infected target cells.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Tumor Necrosis Factor Drug: Interferon gamma-1b |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
Official Title: | A Randomized Multicenter Phase II Trial of Recombinant Tumor Necrosis Factor and Recombinant Human Interferon-Gamma in Patients With AIDS Related Complex |
Estimated Enrollment: | 30 |
Recombinant TNF and recombinant IFN-G have been shown to be effective against the virus which causes AIDS and ARC in some laboratory studies, but may increase virus replication in other laboratory studies. Previous studies in humans showed no increase in virus cultures and some decrease in measurements of virus. Extensive preclinical data show that TNF and IFN-G are more effective together than separately in laboratory and animal studies. As single agents, both TNF and IFN-G have modest effect against HIV. Studies have demonstrated that TNF and IFN-G, in combination, can not only inhibit HIV infection of previously uninfected cells, but also can selectively induce the destruction of acutely infected target cells.
Patients with ARC who are positive for HIV antibody are randomized to receive one of three treatment arms: (1) TNF alone by intramuscular injection (IM); (2) IFN-G alone by IM; (3) TNF plus IFN-G. Patients receive IM injections 3 times weekly for 4 months (16 weeks). Repeated physical examinations and laboratory tests are used to monitor patients' safety. Serial HIV cultures and core antigen assays are employed to obtain evidence of antiviral activity and serial T cell and skin tests are used to measure immunologic effect.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients who have a primary diagnosis of AIDS related complex (ARC) including lymphadenopathy syndrome (LAS), who are positive for HIV antibody, have a minimum life expectancy of 3 months, and have one or more of the following symptoms for = or > 30 days:
Concurrent Medication:
Allowed:
Severe rigors may be treated (or prevented) with meperidine 50 mg IV on an as needed basis in the absence of systolic hypotension < 80 mm Hg.
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Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Study ID Numbers: | ACTG 025 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001004 |
Health Authority: | United States: Federal Government |
Tumor Necrosis Factor Interferon-gamma, Recombinant HIV Antigens Immunologic Surveillance |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Virus Diseases Sexually Transmitted Diseases, Viral Necrosis Interferon Type II HIV Infections Interferons |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes Interferon-gamma, Recombinant |
Anti-Infective Agents RNA Virus Infections Pathologic Processes Slow Virus Diseases Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |