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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 enrolled in NIAID-funded studies investigating the use of laboratory-made IL-2 for the treatment of HIV infection.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interleukin-2

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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