A Double Blind Phase II Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery in Subjects on Potent Antiretroviral Therapy With Plasma HIV-1 RNA Levels of 200 Copies Per Milliliter or Less
18 Years
N/A
Both
HIV Infections
Trial Information
A Double Blind Phase II Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery in Subjects on Potent Antiretroviral Therapy With Plasma HIV-1 RNA Levels of 200 Copies Per Milliliter or Less
Antiretroviral therapy (ART) has dramatically improved the clinical outcome for HIV infected
adults; however, some people on potent ART experience poor recovery of CD4 counts despite
maximum suppression of viral load. Such uncontrolled HIV infection is associated with the
reduced ability by the human body to create new T cells (or thymopoiesis). HIV infected
adults experiencing reduced thymopoiesis are at increased risk of clinical disease
progression.
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.
Inclusion Criteria:
- HIV infected
- 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:
- Active pancreatitis
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Outcome Measure:
Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)
Outcome Description:
Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.
Outcome Time Frame:
Pre-entry, entry, study week 12
Safety Issue:
No
Principal Investigator
Jeffrey M. Jacobson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
A5212
NCT ID:
NCT00376935
Start Date:
December 2006
Completion Date:
September 2008
Related Keywords:
- HIV Infections
- Treatment Experienced
- HIV Infections
- Acquired Immunodeficiency Syndrome
Name | Location |
|---|---|
| UCLA CARE Center CRS | Los Angeles, California 90095 |
| USC CRS | Los Angeles, California 90033 |
| Stanford CRS | Palo Alto, California 94305 |
| Ucsd, Avrc Crs | San Diego, California |
| Harbor-UCLA Med. Ctr. CRS | Torrance, California 90502 |
| Univ. of Miami AIDS CRS | Miami, Florida 33136 |
| Bmc Actg Crs | Boston, Massachusetts 02118 |
| Washington U CRS | St. Louis, Missouri |
| NY Univ. HIV/AIDS CRS | New York, New York 10016 |
| Univ. of Rochester ACTG CRS | Rochester, New York 14642 |
| Unc Aids Crs | Chapel Hill, North Carolina 27599 |
| Duke Univ. Med. Ctr. Adult CRS | Durham, North Carolina 27710 |
| Case CRS | Cleveland, Ohio 44106 |
| MetroHealth CRS | Cleveland, Ohio |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia, Pennsylvania 19104 |
| University of Washington AIDS CRS | Seattle, Washington 98122 |
| HIV Prevention & Treatment CRS | New York, New York 10032 |
| The Ohio State University Medical Center | Columbus, Ohio 43210 |
| The Ponce de Leon Ctr. CRS | Atlanta, Georgia 30308 |
| IHV Baltimore Treatment CRS | Baltimore, Maryland 21201 |
| AIDS Care CRS | Rochester, New York 14607 |
| Vanderbilt Therapeutics CRS | Nashville, Tennessee 37204 |
