Search / Trial NCT00001004

A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients With AIDS Related Complex

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of April 22, 2024

Completed

Keywords

Tumor Necrosis Factor Interferon Gamma, Recombinant Hiv Antigens Immunologic Surveillance Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex

Description

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 HI...

Gender

All

Eligibility criteria

  • 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:
  • Fever.
  • Night sweats.
  • Fatigue.
  • Oral thrush.
  • Hairy leukoplakia.
  • Diarrhea.
  • Weight loss < 10 percent.
  • Patients must be able to sign a written informed consent form, which must be obtained prior to treatment.
  • Concurrent Medication:
  • Allowed:
  • Acetaminophen for temperature rise of > 38.5 degrees C - 650 mg by mouth every 4 hours on an as needed basis.
  • 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.
  • -
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following are excluded:
  • Clinically significant cardiac disease - New York Heart Association Class II, III, or IV.
  • Hemorrhagic diathesis (including hemophilia) or active bleeding disorder (e.g., genitourinary, gastrointestinal).
  • Clinically apparent vascular disease (including a prior history of pulmonary embolus, deep venous thrombosis, or peripheral arterial occlusive disease).
  • Concurrent Medication:
  • Excluded:
  • Medications required for the treatment of active cardiac disease including cardiac glycosides, antiarrhythmics and antianginal agents.
  • Anticoagulants.
  • Thrombolytic agents.
  • Nonsteroidal anti-inflammatory drugs.
  • Ongoing therapy with vasodilators.
  • Aspirin.
  • Corticosteroids.
  • Antihistamines.
  • Barbiturates.
  • Excluded within 4 weeks of study entry:
  • Antiviral chemotherapy.
  • Immunotherapy.
  • Excluded within 12 weeks of study entry:
  • Suramin.
  • Patients with the following are excluded:
  • AIDS-associated opportunistic infection.
  • Lipoprotein disorders.
  • Hemophilia.
  • Prior Medication:
  • Excluded:
  • Interferon gamma.
  • Tumor necrosis factor.

Attachments

readout_NCT00001004_2024-04-22.pdf

4.5 MB

NCT00001004_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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