Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.

Key facts

Study ID

NCT00376935

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

99

Starts

2006-12-01

Expected to finish

2008-09-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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