Overview

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

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
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 can increase CD4 counts in treatment-experienced HIV infected adults.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
AIDS Clinical Trials Group
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

- 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