Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT00376935
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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00376935
Study Brief:
Protocol Section:
NCT00376935