NCT00099671

Brief Summary

The purpose of this study is to determine the safety of a single, under-the-skin dose of interleukin-7 (IL-7) in HIV infected people currently taking anti-HIV drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

December 17, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

December 17, 2004

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Safety, as assessed by dose-limiting toxicities

Secondary Outcomes (8)

  • Change in IL-7 plasma level from study entry to Day 28

  • concentrations of recombinant human IL-7 (rhIL-7) at study entry (prior to dose) and at 0.5, 1.0, 1.5, 2.0, 2.5, 4, 8, 12, 24, 48, and 72 hours after dose

  • T-cell proliferation and activation status

  • lymphocyte subsets prior to study entry, study entry and on Days 1, 2, 4, 14, and 28

  • anti-IL-7 antibodies prior to study entry and on Days 28 and 56

  • +3 more secondary outcomes

Interventions

Recombinant human interleukin-7DRUG

Eligibility Criteria

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

You may qualify if:

  • HIV infected
  • 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.

You may not qualify if:

  • Lymphadenopathy greater than 2.0 cm
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Univ. of California Davis Med. Ctr., ACTU

Sacramento, California, 95817, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 33136-1013, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612-3806, United States

Location

Case CRS

Cleveland, Ohio, 44106-5083, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109-1998, United States

Location

Related Publications (6)

  • 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.

    PMID: 11574281BACKGROUND

  • 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.

    PMID: 11207251BACKGROUND

  • 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.

    PMID: 12959322BACKGROUND

  • 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.

    PMID: 15482104BACKGROUND

  • 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.

    PMID: 19380868RESULT

  • 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.

    PMID: 23589672DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Interleukin-7

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 ProteinsProteinsBiological Factors

Study Officials

  • Irini Sereti, MD

    National Institute for Allergy and Infectious Diseases, National Institutes of Health

    STUDY CHAIR

  • Michael M. Lederman, MD

    Case Western Reserve University, University Hospitals of Cleveland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2004

First Posted

December 20, 2004

Study Start

April 1, 2005

Study Completion

April 1, 2007

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(5)