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

NCT00001004 | Completed Phase 2

• 2 other identifiers: ACTG 02511001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Tumor Necrosis Factor; Interferon-gamma, Recombinant; HIV Antigens; Immunologic Surveillance; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Tumor Necrosis Factor DRUG

Interferon gamma-1b DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Univ of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• Agosti JM, Coombs R, Kidd PG, Paradise M, Sherwin S, Corey L. Randomized phase II trial of recombinant tumor necrosis factor (rTNF) and recombinant interferon-gamma (rIFN-gamma) in patients with ARC. Int Conf AIDS. 1989 Jun 4-9;5:558 (abstract no MCP101)

  BACKGROUND

• Agosti JM, Coombs RW, Collier AC, Paradise MA, Benedetti JK, Jaffe HS, Corey L. A randomized, double-blind, phase I/II trial of tumor necrosis factor and interferon-gamma for treatment of AIDS-related complex (Protocol 025 from the AIDS Clinical Trials Group). AIDS Res Hum Retroviruses. 1992 May;8(5):581-7. doi: 10.1089/aid.1992.8.581.

  PMID: 1515211 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Tumor Necrosis Factor-alpha; interferon gamma-1b

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Monokines; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Tumor Necrosis Factors; Blood Proteins; Proteins; Biological Factors

Study Officials

• Kaplan L

  STUDY CHAIR

• Corey L

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: February 1, 1990
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)