NCT00311688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

5 years

First QC Date

April 4, 2006

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

IL-2Immunomodulatory Therapies

Outcome Measures

Primary Outcomes (1)

  • CD4 counts in participants treated with IL-2 and discontinued antiretroviral therapy

    Throughout study

Study Arms (1)

1

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

Drug: Interleukin-2

Interventions

Interleukin-2DRUG

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

Also known as: IL-2
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIH Intramural Research Program ACTG CRS

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 15767224BACKGROUND

  • 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.

    PMID: 15731201BACKGROUND

  • 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.

    PMID: 17285152BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Richard T. Davey, Jr., MD, FACP

    NIAID HIV Research Clinic, Laboratory of Immunoregulation, NIAID

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

December 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(1)