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NCT00001131
Procedure for Initiation, Administration, and Discontinuation of Interleukin-2 (IL-2) Therapy in Conjunction With Highly Active Antiretroviral Therapy
NA trial testing Aldesleukin in HIV Infections in 42 participants. Completed in 1 June 2007.
1 June 2007
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 May 2004 |
| Primary completion | 1 June 2007 |
| Estimated completion | 1 June 2007 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aldesleukin (ALDESLEUKIN) — full drug profile →
- HAART — full drug profile →
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Eligibility, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Augmentation and extention of HTL response
Time frame: Throughout study -
Reduction in extent of damage and acceleration of immune system recovery
Time frame: Throughout study -
Delay of and reduction in recurrent viremia compared to historical controls
Time frame: Throughout study
Sponsor's own description
The purpose of this study is to find out if the immune systems of HIV-positive patients can be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early stages of HIV infection. IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV spreads throughout the body by invading CD4 cells, which are cells of the immune system that fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions. This study will look at how the HIV virus acts during the early stages of HIV infection, how the immune system responds to HIV, and what impact early treatment with anti-HIV medications has on the course of HIV infection.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00001131
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
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- NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
- NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00001131 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 14 May 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00001131.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing