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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: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in CD4 count from baseline to week 32.
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
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2005-09 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
What the finished NCT00110812 record still lists
NCT00110812 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (40% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
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Where NCT00110812's enrollment target sits among peer trials
267 134th of 542 higher than 409 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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