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NCT00110812 · ClinicalTrials.gov registry record · Phase 2

Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People

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

Completed
Registry status
Phase 2
Development phase
267
Enrollment target
20
Study locations

NCT00110812 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 267 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00110812, 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
267 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to patients with early HIV infection, will produce no change in HIV viral load and increases in CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.

Conditions Studied

Interventions

  • DRUG IL-2

Study Locations (20)

Texas

  • Michael E. DeBakey VAMC CRS - Houston
  • Thomas Street Clinic CRS - Houston
  • South Texas Veterans Health Care System, Immunosuppression Clinic CRS - San Antonio

Buenos Aires

  • Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS - Ciudad de Buenos Aires
  • Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS - Ciudad de Buenos Aires
  • Funcei Crs - Ciudad de Buenos Aires

Queensland

  • Queensland Health - AIDS Med. Unit CRS - Brisbane
  • Gladstone Road Medical Ctr. CRS - Highgate Hill
  • Gold Coast Sexual Health Clinic CRS - Miami

New York

  • Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) - New York
  • Lincoln Hosp. & Med. Ctr. CRS - The Bronx

California

  • VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS - Los Angeles

District of Columbia

  • Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS - Washington D.C.

Maryland

  • NIH Clinical Ctr., NIAID HIV Clinic CRS - Bethesda

Michigan

  • Henry Ford Hosp. CRS - Detroit

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2005-09
Est. Completion 2011-02
Phase Phase 2

What the Registry Record Tells You About NCT00110812

The ClinicalTrials.gov registry entry for NCT00110812 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (40% 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 1 intervention - of which IL-2 is the first listed.

NCT00110812 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Texas, Buenos Aires, Queensland.

Frequently Asked Questions

What is clinical trial NCT00110812 about?

NCT00110812 is a clinical study titled "Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People". The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Stud...

What is the current status of trial NCT00110812?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 267 participants. The study started on 2005-09. Estimated completion is 2011-02.

What conditions does trial NCT00110812 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00110812?

The interventions under investigation include: IL-2 (DRUG).

Who is sponsoring clinical trial NCT00110812?

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 NCT00110812 being conducted?

This trial has 20 study locations across California, District of Columbia, Maryland, Michigan, New York. 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.