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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311688
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : November 9, 2016
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Interleukin-2 Phase 1 Phase 2

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).

Study Type : Observational [Patient Registry]
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: An Omnibus Proleukin (IL-2) Trial in HIV Infected Patients Including Interrupted Versus Continuous Antiretrovirals (OPTICA)
Study Start Date : December 2003
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Group/Cohort Intervention/treatment
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
Other Name: IL-2

Primary Outcome Measures :
  1. CD4 counts in participants treated with IL-2 and discontinued antiretroviral therapy [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311688

United States, Maryland
NIH Intramural Research Program ACTG CRS
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Richard T. Davey, Jr., MD, FACP NIAID HIV Research Clinic, Laboratory of Immunoregulation, NIAID

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00311688     History of Changes
Obsolete Identifiers: NCT00359749
Other Study ID Numbers: IRP 030/OPTICA
10476 ( Registry Identifier: DAIDS ES )
IRP 030
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2013

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs