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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00311688
First received: April 4, 2006
Last updated: November 19, 2013
Last verified: November 2013
  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 1
Phase 2

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

Resource links provided by NLM:


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 ]

Study Start Date: December 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

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, Maryland
NIH Intramural Research Program ACTG CRS
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: Richard T. Davey, Jr., MD, FACP NIAID HIV Research Clinic, Laboratory of Immunoregulation, NIAID
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00311688     History of Changes
Obsolete Identifiers: NCT00359749
Other Study ID Numbers: IRP 030/OPTICA, 10476, IRP 030, OPTICA
Study First Received: April 4, 2006
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
IL-2
Immunomodulatory Therapies

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Immunologic Factors
Interleukin-2
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014