Umbrella Study for HIV Infected Adults Enrolled in NIAID-Funded Interleukin-2 Studies

Completed

Conditions studied: HIV Infections

In brief

Interleukin-2 (IL-2) is a protein found naturally in the blood that helps boost the immune system. The purpose of this study is to provide long-term treatment and monitoring of HIV infected people enrolled in NIAID-funded studies investigating the use of laboratory-made IL-2 for the treatment of HIV infection.

Key facts

Study ID

NCT00311688

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

Starts

2003-12-01

Expected to finish

2008-12-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infected
• Current participation and presently in good standing in a NIAID/CCMD clinical trial involving the use of IL-2 for the treatment of HIV-1 infection. Additional HIV-1 infected people who are IL-2 naive may be selected by the investigator for this study.
• Willing to take antiretrovirals within a 10-day period surrounding each IL-2 cycle. Individual protocols may be modified as needed by the investigator to permit IL-2 therapy in the absence of antiretrovirals.
• Willing to accept additional IL-2 therapy when needed
• Willing to use acceptable forms of contraception during a minimum 10-day period surrounding each IL-2 injection

You may not qualify if…

• History of noncompliance with prior NIAID/CCMD protocols
• Any organic central nervous system (CNS) abnormality requiring treatment with antiseizure medication
• Unless previously exempted for this requirement, current or history of Crohn's disease, psoriasis, or other autoimmune or inflammatory disease with potentially life-threatening complications
• Significant heart, lung, kidney, rheumatologic, gastrointestinal, or CNS disease that may pose an unacceptable risk to the participant during IL-2 therapy
• Psychiatric illness that, in the opinion of the investigator, may interfere with the study
• Current or recent substance abuse that, in the opinion of the investigator, may interfere with the study
• Refuse to follow Clinical Center policy on partner notification
• History of optic neuritis
• Refuse to allow extra blood specimens to be stored for potential use in future studies of HIV-1 infection or the immune system

Where it is running

• NIH Intramural Research Program ACTG CRS — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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