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

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00311688

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Interleukin-2	Phase I Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Aldesleukin Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Omnibus Proleukin (IL-2) Trial in HIV Infected Patients Including Interrupted Versus Continuous Antiretrovirals (OPTICA)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

CD4 counts in participants treated with IL-2 and discontinued antiretroviral therapy [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1266
Study Start Date:	January 1992
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Individuals will follow the schedule of the study they are participating in	Drug: Interleukin-2 Biological response modifier in liquid form; dosage of drug will vary by study

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 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311688

Locations

United States, District of Columbia
George Washington University Medical Center	Active, not recruiting
Washington, District of Columbia, United States, 20037
United States, Maryland
National Institute of Allergy and Infectious Disease Clinical Center	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Patient Recruitment and Public Liaison Office 800-411-1222 prpl@mail.cc.nih.gov
United States, Texas
University of Texas	Active, not recruiting
Dallas, Texas, United States, 75216

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Richard T. Davey, Jr., MD, FACP

NIAID HIV Research Clinic, Laboratory of Immunoregulation, NIAID

More Information

Click here for more information about interleukin-2 This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español This link exits the ClinicalTrials.gov site

Publications:

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

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. Epub 2005 Feb 24.

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

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	IRP 030, OPTICA, ICARUS, 1-Z01-AI00865-01, 01-I-0225
Study First Received:	April 4, 2006
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00311688
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

IL-2
Immunomodulatory Therapies

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Aldesleukin
Interleukin-2
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009