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NCT00001004 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT00001004 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001004, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DRUG Interferon gamma-1b
  • DRUG Tumor Necrosis Factor

Study Locations (1)

Washington

  • Univ of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 30 participants
Est. Completion 1990-02
Phase Phase 2

What the Registry Record Tells You About NCT00001004

The ClinicalTrials.gov registry entry for NCT00001004 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (93% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Interferon gamma-1b is the first listed.

NCT00001004 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT00001004 about?

NCT00001004 is a clinical study titled "A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients With AIDS Related Complex". 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 o...

What is the current status of trial NCT00001004?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. Estimated completion is 1990-02.

What conditions does trial NCT00001004 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00001004?

The interventions under investigation include: Interferon gamma-1b (DRUG), Tumor Necrosis Factor (DRUG).

Who is sponsoring clinical trial NCT00001004?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001004 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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