Status:
COMPLETED
Umbrella Study for HIV Infected Adults Enrolled in NIAID-Funded Interleukin-2 Studies
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
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 enr...
Detailed Description
IL-2 is a biological response modifier that can improve the body's response to disease. It is hoped that IL-2 treatment can help restore CD4 cell counts and immune function in people whose immune syst...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00311688
Start Date
December 1 2003
End Date
December 1 2008
Last Update
November 1 2021
Active Locations (1)
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1
NIH Intramural Research Program ACTG CRS
Bethesda, Maryland, United States, 20892