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

NCT ID: NCT00311688

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2003-12-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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 systems have been damaged by HIV. Over the last 10 years, NIAID has sponsored a number of important studies of IL-2 in HIV infected people; many of these trials are ongoing. This study was developed in an effort consolidate these separate, smaller trials into one larger study so that results between the trials can be shared and used to develop future protocols. This study is an umbrella study that will provide long-term administrative support, treatment, and monitoring for ongoing Phase I and II IL-2 trials and their participants. It is primarily intended for patients in the extension phases of any previous NIAID Clinical Center HIV Program (NIAID/CCMD) intramural research protocols in which IL-2 therapy continues to be offered. Blood collection will occur through a patient's participation in this study.

Participants will continue to follow the protocol in which they originally enrolled. A desired therapeutic goal or "CD4 plateau" will be used in most cases to help clinicians determine when a participant requires additional IL-2. In general, if a participant has two or more consecutive CD4 counts below the CD4 plateau, additional IL-2 will be administered to that patient. In maintaining uniformity among the many trials being consolidated under this trial, the frequency and nature of study visits will be solely dictated by this umbrella study. Participants will also be asked to join an optional substudy: Interrupted Versus Continuous Antiretrovirals Involving Randomization from the Umbrella Study (ICARUS).

Conditions

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HIV Infections

Keywords

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IL-2 Immunomodulatory Therapies

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Individuals will follow the schedule of the study they are participating in

Interleukin-2

Intervention Type DRUG

Biological response modifier in liquid form; dosage of drug will vary by study

Interventions

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Interleukin-2

Biological response modifier in liquid form; dosage of drug will vary by study

Intervention Type DRUG

Other Intervention Names

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IL-2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard T. Davey, Jr., MD, FACP

Role: STUDY_CHAIR

NIAID HIV Research Clinic, Laboratory of Immunoregulation, NIAID

Locations

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NIH Intramural Research Program ACTG CRS

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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Anaya JP, Sias JJ. The use of interleukin-2 in human immunodeficiency virus infection. Pharmacotherapy. 2005 Jan;25(1):86-95. doi: 10.1592/phco.25.1.86.55629.

Reference Type BACKGROUND
PMID: 15767224 (View on PubMed)

Marchetti G, Franzetti F, Gori A. Partial immune reconstitution following highly active antiretroviral therapy: can adjuvant interleukin-2 fill the gap? J Antimicrob Chemother. 2005 Apr;55(4):401-9. doi: 10.1093/jac/dkh557. Epub 2005 Feb 24.

Reference Type BACKGROUND
PMID: 15731201 (View on PubMed)

Temesgen Z. Interleukin-2 for the treatment of human immunodeficiency virus infection. Drugs Today (Barc). 2006 Dec;42(12):791-801. doi: 10.1358/dot.2006.42.12.1025703.

Reference Type BACKGROUND
PMID: 17285152 (View on PubMed)

Other Identifiers

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10476

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRP 030

Identifier Type: -

Identifier Source: secondary_id

OPTICA

Identifier Type: -

Identifier Source: secondary_id

IRP 030/OPTICA

Identifier Type: -

Identifier Source: org_study_id

NCT00359749

Identifier Type: -

Identifier Source: nct_alias