Safety of Interleukin-7 in HIV Infected People Currently Taking Anti-HIV Drugs
NCT ID: NCT00099671
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2005-04-30
2007-04-30
Brief Summary
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Detailed Description
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This study will last 13 weeks. Participants will be stratified into two groups by viral load: Stratum 1 participants will have viral loads of less than 50 copies/ml, and Stratum 2 participants will have viral loads between 50 and 50,000 copies/ml. Participants will receive one dose of either IL-7 or placebo at study entry. Five different dosing levels of IL-7 will be tested sequentially in both strata. Dose escalation will occur independently in each stratum and enrollment in a stratum will end when the maximum-tolerated dose is reached. As of 10/23/06, due to adverse events associated with the 60 mcg/kg dose level, all participants will receive up to the 30 mcg/kg dose level, with no further dose escalation. New participants will enroll in Stratum 2 only.
There will be 9 study visits; medical and medication history, a physical exam, lymph node and spleen assessment, and blood collection will occur at most visits. Participants will undergo an electrocardiogram at study entry and on Day 1, and a spleen ultrasound at Week 3. Urine collection will occur on Day 4 and at Weeks 2 and 3.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Recombinant human interleukin-7
Eligibility Criteria
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Inclusion Criteria
* Currently on ART consisting of at least 3 antiretroviral drugs for at least 12 months prior to study entry and stable (no change in dose) on treatment for at least 3 months prior to study entry
* CD4 count of 100 cells/mm3 or more within 42 days of study entry
* Viral load of 50,000 copies/ml or less within 42 days of study entry
* Willing to use acceptable forms of contraception
* Participants with a Category C AIDS-defining illness during the 12 months prior to study entry may be eligible as long as their CD4 count is 200 cells/mm3 or more at screening. Participants with Kaposi's sarcoma may also be eligible for this study.
Exclusion Criteria
* Known allergy or sensitivity to study drug or its formulations
* Current drug or alcohol abuse
* Serious illness or hospitalization that, in the opinion of the site investigator, may interfere with the study results
* Prior use of any interleukins
* Systemic cancer chemotherapy, systemic investigational agents, or immunomodulators (e.g., growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interferons) within 90 days prior to study entry
* Heparin within 96 hours prior to study entry, or anticipating the need for heparin within 96 hours after the study injection
* History of cancer (except basal carcinoma of the skin or Kaposi's sarcoma)
* Enlargement of spleen
* History of hypercoagulability (deep vein thrombosis or pulmonary embolism)
* History of seizure disorder
* History of extensive psoriasis, Crohn's disease, uveitis, or other autoimmune disease having induced severe complications
* Significant psychiatric, cardiac, pulmonary, thyroid, renal, or neurological disease requiring therapy
* Positive hepatitis B surface antigen or positive hepatitis C antibody at screening
* Plan to start new ART within 8 weeks after study entry
* Breastfeeding
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Irini Sereti, MD
Role: STUDY_CHAIR
National Institute for Allergy and Infectious Diseases, National Institutes of Health
Michael M. Lederman, MD
Role: STUDY_CHAIR
Case Western Reserve University, University Hospitals of Cleveland
Locations
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Univ. of California Davis Med. Ctr., ACTU
Sacramento, California, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Case CRS
Cleveland, Ohio, United States
MetroHealth CRS
Cleveland, Ohio, United States
Countries
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References
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Fry TJ, Mackall CL. Interleukin-7: master regulator of peripheral T-cell homeostasis? Trends Immunol. 2001 Oct;22(10):564-71. doi: 10.1016/s1471-4906(01)02028-2.
Geiselhart LA, Humphries CA, Gregorio TA, Mou S, Subleski J, Komschlies KL. IL-7 administration alters the CD4:CD8 ratio, increases T cell numbers, and increases T cell function in the absence of activation. J Immunol. 2001 Mar 1;166(5):3019-27. doi: 10.4049/jimmunol.166.5.3019.
Kedzierska K, Crowe SM. Cytokines and HIV-1: interactions and clinical implications. Antivir Chem Chemother. 2001 May;12(3):133-50. doi: 10.1177/095632020101200301.
Pett SL, Kelleher AD. Cytokine therapies in HIV-1 infection: present and future. Expert Rev Anti Infect Ther. 2003 Jun;1(1):83-96. doi: 10.1586/14787210.1.1.83.
Sereti I, Dunham RM, Spritzler J, Aga E, Proschan MA, Medvik K, Battaglia CA, Landay AL, Pahwa S, Fischl MA, Asmuth DM, Tenorio AR, Altman JD, Fox L, Moir S, Malaspina A, Morre M, Buffet R, Silvestri G, Lederman MM; ACTG 5214 Study Team. IL-7 administration drives T cell-cycle entry and expansion in HIV-1 infection. Blood. 2009 Jun 18;113(25):6304-14. doi: 10.1182/blood-2008-10-186601. Epub 2009 Apr 20.
Vandergeeten C, Fromentin R, DaFonseca S, Lawani MB, Sereti I, Lederman MM, Ramgopal M, Routy JP, Sekaly RP, Chomont N. Interleukin-7 promotes HIV persistence during antiretroviral therapy. Blood. 2013 May 23;121(21):4321-9. doi: 10.1182/blood-2012-11-465625. Epub 2013 Apr 15.
Other Identifiers
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10022
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5214
Identifier Type: -
Identifier Source: secondary_id
A5214
Identifier Type: -
Identifier Source: org_study_id