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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00311688 |
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 |
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HIV Infections |
Drug: Interleukin-2 |
Phase I Phase II |
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) |
Estimated Enrollment: | 1266 |
Study Start Date: | January 1992 |
Arms | Assigned Interventions |
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1: Experimental
Individuals will follow the schedule of the study they are participating in
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Drug: Interleukin-2
Biological response modifier in liquid form; dosage of drug will vary by study
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Chair: | Richard T. Davey, Jr., MD, FACP | NIAID HIV Research Clinic, Laboratory of Immunoregulation, NIAID |
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: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00311688 History of Changes |
Health Authority: | United States: Food and Drug Administration |
IL-2 Immunomodulatory Therapies |
Virus Diseases Sexually Transmitted Diseases, Viral Aldesleukin Analgesics, Non-Narcotic Interleukin-2 HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Peripheral Nervous System Agents Analgesics Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Infection Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases |
Sensory System Agents Analgesics, Non-Narcotic HIV Infections Interleukin-2 Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Analgesics Central Nervous System Agents Retroviridae Infections |