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

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jeffrey M. Jacobson, MD

Principal Investigator

Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine

Eligibility Criteria

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

Treatment Details

Interventions

• Palifermin (Growth Factor)

Participant Groups

Group I: 4 Experimental Treatment 1 Intervention

Participants will receive palifermin 60 mcg/kg injection on Days 1, 2, and 3

Group II: 3 Experimental Treatment 1 Intervention

Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3

Group III: 2 Experimental Treatment 1 Intervention

Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3

Group IV: 1 Placebo Group 1 Intervention

Participants will receive palifermin placebo injection on Days 1, 2, and 3

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Bmc Actg Crs Boston, MA

IHV Baltimore Treatment CRS Baltimore, MD

Columbia P&S CRS New York, NY

Washington U CRS Saint Louis, MO

More Trial Locations

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3361

Patients Recruited

5,516,000+

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Collaborator

Trials

103

Patients Recruited

74,200+

AIDS Clinical Trials Group

Collaborator

Trials

101

Patients Recruited

73,600+