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NCT00006291 · ClinicalTrials.gov registry record · Phase 2

Safety and Effectiveness of Adding Either an HIV Vaccine, Interleukin-2, or Both to a Patient's Anti-HIV Drug Combination

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

Completed
Registry status
Phase 2
Development phase
100
Enrollment target
20
Study locations

NCT00006291 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 100 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT00006291, 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
100 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to see if adding an HIV vaccine (ALVAC-HIV vCP1452), IL-2 (interleukin-2, a protein found in the blood that helps boost the immune system), or both to anti-HIV-drug therapy is safe, tolerable, and effective in controlling viral load (level of HIV in the body). (This study has been changed to clarify drug name.) Anti-HIV drugs can help reduce a patient's viral load. However, HIV can still remain in CD4 cells (cells of the immune system that help fight infection). Combining an HIV vaccine, IL-2, or both with anti-HIV drugs may help reduce the number of HIV-infected cells.

Conditions Studied

Interventions

  • DRUG Aldesleukin
  • BIOLOGICAL ALVAC(2)120(B,MN)GNP (vCP1452)

Study Locations (20)

California

  • USC CRS - Los Angeles
  • UCLA CARE Center CRS - Los Angeles
  • Stanford CRS - Palo Alto
  • Ucsf Aids Crs - San Francisco
  • Santa Clara Valley Med. Ctr. - San Jose
  • San Mateo County AIDS Program - San Mateo
  • Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic - San Rafael
  • Harbor-UCLA Med. Ctr. CRS - Torrance

Indiana

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
  • Indiana Univ. School of Medicine, Wishard Memorial - Indianapolis
  • Methodist Hosp. of Indiana - Indianapolis

New York

  • Beth Israel Med. Ctr., ACTU - New York
  • NY Univ. HIV/AIDS CRS - New York

Alabama

  • Alabama Therapeutics CRS - Birmingham

Colorado

  • University of Colorado Hospital CRS - Aurora

Florida

  • Univ. of Miami AIDS CRS - Miami

Georgia

  • The Ponce de Leon Ctr. CRS - Atlanta

Hawaii

  • Univ. of Hawaii at Manoa, Leahi Hosp. - Honolulu

Trial Details

FieldValue
Enrollment Target 100 participants
Est. Completion 2005-10
Phase Phase 2

What the Registry Record Tells You About NCT00006291

The ClinicalTrials.gov registry entry for NCT00006291 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 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 (78% 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 Aldesleukin is the first listed.

NCT00006291 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Indiana, New York.

Frequently Asked Questions

What is clinical trial NCT00006291 about?

NCT00006291 is a clinical study titled "Safety and Effectiveness of Adding Either an HIV Vaccine, Interleukin-2, or Both to a Patient's Anti-HIV Drug Combination". The purpose of this study is to see if adding an HIV vaccine (ALVAC-HIV vCP1452), IL-2 (interleukin-2, a protein found in the blood that helps boost the immune system), or both to anti-HIV-drug therapy is safe, tolerable, and effective in controlling viral load (level of HIV in the body). (This stud...

What is the current status of trial NCT00006291?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. Estimated completion is 2005-10.

What conditions does trial NCT00006291 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00006291?

The interventions under investigation include: Aldesleukin (DRUG), ALVAC(2)120(B,MN)GNP (vCP1452) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00006291?

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 NCT00006291 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.