Effect of Interleukin-2 on HIV Treatment Interruption
An Open-Label, Pilot Study Utilizing CD4 T-Cell Counts Lower Than 350 Cells/mm3 as the Threshold for Restarting Therapy With Potent Antiretroviral Therapy With or Without Interleukin-2 to Determine the Effect of Pulse Therapy on the Characteristics of Treatment Interruptions
2 other identifiers
interventional
80
1 country
17
Brief Summary
Interleukin-2 (IL-2) helps the body make infection-fighting white blood cells, including CD4 and CD8 T cells. One HIV treatment strategy is planned treatment interruption (stopping anti-HIV drugs when CD4 count and level of virus in the blood are at certain levels). The purpose of this study is to see if IL-2 used with potent anti-HIV drugs allows for longer HIV treatment interruptions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
17 active sites
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
First Submitted
Initial submission to the registry
May 1, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedNovember 1, 2021
October 1, 2021
May 1, 2001
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- On stable, potent ART regimen for at least 3 months prior to study entry
- Viral load of less than 400 copies/ml for at least 6 months prior to study entry
- Viral load of less than 200 copies/ml at screening
- CD4 count of 500 cells/mm3 or greater at screening
- Agree to use acceptable methods of contraception
- Agree to be followed on this study for at least 4 years
- Primary care provider willing to have the patient in the study and to comply with study guidelines
You may not qualify if:
- Active or past significant AIDS-related illness. Patients with a history of minimal (less than 10 lesions) cutaneous Kaposi's sarcoma, pulmonary tuberculosis, or bacterial pneumonia are not excluded.
- Immunomodulators within 1 month of study entry
- Hydroxyurea within 3 months of study entry
- Prior IL-2 treatment
- Drugs to treat heart disease within 30 days of study entry
- Serious heart problems
- Cancer requiring anti-cancer drugs
- Thyroid problems. If the condition has been controlled by drugs for at least 3 months prior to study entry, the patient is not excluded.
- Uncontrolled diabetes
- Breathing or stomach problems that, in the opinion of the investigator, may affect the safety of the patient
- History of autoimmune disease, including inflammatory bowel disease, psoriasis, and optic neuritis
- Organ transplant
- History of neurological disorder or mental illness that, in the opinion of the investigator, may interfere with study requirements
- Alcohol or drug abuse that, in the opinion of the investigator, may interfere with study requirements
- Astemizole, midazolam, or triazolam within 2 weeks of study entry
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
UCLA CARE Center CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, 943055107, United States
Santa Clara Valley Med. Ctr.
San Jose, California, United States
San Mateo County AIDS Program
San Mateo, California, 943055107, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
Washington U CRS
St Louis, Missouri, 63108, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, 681985130, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
Cornell CRS
New York, New York, 10021, United States
Weill Med. College of Cornell Univ., The Cornell CTU
New York, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710, United States
Case CRS
Cleveland, Ohio, 44106, United States
MetroHealth CRS
Cleveland, Ohio, 441091998, United States
Pitt CRS
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (7)
Conrad A. Interleukin-2--where are we going? J Assoc Nurses AIDS Care. 2003 Nov-Dec;14(6):83-8. doi: 10.1177/1055329003255620.
PMID: 14682072BACKGROUNDDavey RT Jr, Murphy RL, Graziano FM, Boswell SL, Pavia AT, Cancio M, Nadler JP, Chaitt DG, Dewar RL, Sahner DK, Duliege AM, Capra WB, Leong WP, Giedlin MA, Lane HC, Kahn JO. Immunologic and virologic effects of subcutaneous interleukin 2 in combination with antiretroviral therapy: A randomized controlled trial. JAMA. 2000 Jul 12;284(2):183-9. doi: 10.1001/jama.284.2.183.
PMID: 10889591BACKGROUNDSullivan AK, Hardy GA, Nelson MR, Gotch F, Gazzard BG, Imami N. Interleukin-2-associated viral breakthroughs induce HIV-1-specific CD4 T cell responses in patients on fully suppressive highly active antiretroviral therapy. AIDS. 2003 Mar 7;17(4):628-9. doi: 10.1097/00002030-200303070-00020.
PMID: 12598786BACKGROUNDVerheggen R. Immune restoration in patients with HIV infection: HAART and beyond. J Assoc Nurses AIDS Care. 2003 Nov-Dec;14(6):76-82. doi: 10.1177/1055329003259055.
PMID: 14682071BACKGROUNDXu J, Whitman L, Lori F, Lisziewicz J. Methods of using interleukin 2 to enhance HIV-specific immune responses. AIDS Res Hum Retroviruses. 2002 Mar 1;18(4):289-93. doi: 10.1089/088922202753472865.
PMID: 11860676BACKGROUNDHenry K, Katzenstein D, Cherng DW, Valdez H, Powderly W, Vargas MB, Jahed NC, Jacobson JM, Myers LS, Schmitz JL, Winters M, Tebas P; A5102 Study Team of the AIDS Clinical Trials Group. A pilot study evaluating time to CD4 T-cell count <350 cells/mm(3) after treatment interruption following antiretroviral therapy +/- interleukin 2: results of ACTG A5102. J Acquir Immune Defic Syndr. 2006 Jun;42(2):140-8. doi: 10.1097/01.qai.0000225319.59652.1e.
PMID: 16760795RESULTTebas P, Henry WK, Matining R, Weng-Cherng D, Schmitz J, Valdez H, Jahed N, Myers L, Powderly WG, Katzenstein D. Metabolic and immune activation effects of treatment interruption in chronic HIV-1 infection: implications for cardiovascular risk. PLoS One. 2008 Apr 23;3(4):e2021. doi: 10.1371/journal.pone.0002021.
PMID: 18431498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
W. Keith Henry, MD
HIV Program, Hennepin County Medical Center, University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2001
First Posted
August 31, 2001
Study Completion
November 1, 2004
Last Updated
November 1, 2021
Record last verified: 2021-10