Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults
NCT ID: NCT00376935
Last Updated: 2021-11-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2006-12-31
2008-09-30
Brief Summary
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Detailed Description
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The thymus is the primary site for CD4 cell development; research suggests that keratinocyte growth factor (KGF) may enhance thymus activity in individuals who exhibit reduced thymopoiesis. Palifermin is a modified version of the naturally occurring KGF that is approved to treat people with hematologic malignancies. The purpose of this study is to evaluate the safety and efficacy of palifermin in increasing CD4 counts, through enhanced thymopoiesis, in treatment-experienced HIV infected adults with suppressed viral loads but low CD4 counts.
This study will last 24 weeks. Participants will be randomly assigned to one of four arms:
* Arm A participants will receive placebo
* Arm B participants will receive palifermin 20 mcg/kg
* Arm C participants will receive palifermin 40 mcg/kg
* Arm D participants will receive palifermin 60 mcg/kg
Participants will receive intravenous doses of their assigned intervention on Days 1, 2, and 3. All participants must remain on their current ART regimen for the duration of the study. ART will not be provided by the study. There will be six study visits, and they will occur at Weeks 1, 2, 4, 8, 12, and 24. All visits will include a targeted physical exam and blood and urine collection.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Participants will receive palifermin placebo injection on Days 1, 2, and 3
Palifermin placebo
Keratinocyte growth factor placebo administered via injection
2
Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3
Palifermin
Keratinocyte growth factor administered via injection
3
Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3
Palifermin
Keratinocyte growth factor administered via injection
4
Participants will receive palifermin 60 mcg/kg injection on Days 1, 2, and 3
Palifermin
Keratinocyte growth factor administered via injection
Interventions
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Palifermin
Keratinocyte growth factor administered via injection
Palifermin placebo
Keratinocyte growth factor placebo administered via injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving potent ART, defined as a combination of three or more antiretroviral drugs for at least 6 months prior to study entry
* CD4 count of 200 cells/mm3 or less within 30 days prior to study entry
* Documented CD4 count obtained at study screening
* Documented current, persistent viral load less than or equal to 200 copies/ml for at least 6 months prior to study entry
* Willing to use acceptable forms of contraception for the duration of the study
Exclusion Criteria
* Androgens, Immunomodulators (e.g., growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons), or investigational ART within 30 days prior to study entry
* Systemic cancer chemotherapy within 30 days prior to study entry, or history of radiation therapy to the neck and chest regions at any time.
* Allergy or sensitivity to any component of palifermin
* Prior treatment with palifermin or other keratinocyte growth factors
* Current drug or alcohol use that, in the opinion of the investigator, may interfere with study participation
* Serious illness or recent surgery that requires systemic treatment or hospitalization. Participants who have completed therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.
* Active cancer
* HIV-1 RNA levels \>200 copies/mL within 6 months prior to study entry
* Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Jeffrey M. Jacobson, MD
Role: STUDY_CHAIR
Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine
Locations
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USC CRS
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Ucsd, Avrc Crs
San Diego, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States
Bmc Actg Crs
Boston, Massachusetts, United States
Washington U CRS
St Louis, Missouri, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Columbia P&S CRS
New York, New York, United States
Trillium Health ACTG CRS
Rochester, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Case CRS
Cleveland, Ohio, United States
MetroHealth CRS
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Countries
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References
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Aiuti F, Mezzaroma I. Failure to reconstitute CD4+ T-cells despite suppression of HIV replication under HAART. AIDS Rev. 2006 Apr-Jun;8(2):88-97.
Franco JM, Rubio A, Martinez-Moya M, Leal M, Merchante E, Sanchez-Quijano A, Lissen E. T-cell repopulation and thymic volume in HIV-1-infected adult patients after highly active antiretroviral therapy. Blood. 2002 May 15;99(10):3702-6. doi: 10.1182/blood.v99.10.3702.
van den Brink MR, Alpdogan O, Boyd RL. Strategies to enhance T-cell reconstitution in immunocompromised patients. Nat Rev Immunol. 2004 Nov;4(11):856-67. doi: 10.1038/nri1484.
Ye P, Kourtis AP, Kirschner DE. Reconstitution of thymic function in HIV-1 patients treated with highly active antiretroviral therapy. Clin Immunol. 2003 Feb;106(2):95-105. doi: 10.1016/s1521-6616(02)00024-4.
Other Identifiers
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10147
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5212
Identifier Type: -
Identifier Source: secondary_id
A5212
Identifier Type: -
Identifier Source: org_study_id