Status:
COMPLETED
Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 suppressi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00376935
Start Date
December 1 2006
End Date
September 1 2008
Last Update
November 4 2021
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
USC CRS
Los Angeles, California, United States, 90033
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
3
Stanford CRS
Palo Alto, California, United States, 94304
4
Ucsd, Avrc Crs
San Diego, California, United States, 92103