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:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT00100633
Eligibility Criteria:
Inclusion Criteria for HIV Infected Participants:
* HIV-1 infection
* If receiving combination antiretroviral therapy (ART), must have been on ART for at least 3 months prior to study entry. Patients who anticipate a change in treatment (either initiating ART or stopping ART) in the next 7 months are not eligible.
* CD4 count of 250 cells/mm3 or greater
* Negative HBsAb, HBsAg, and HBcAb
* Willing to use acceptable forms of contraception while on study treatment and for 24 weeks after study treatment has ended
Inclusion Criteria for HIV Uninfected Participants:
* HIV uninfected
* Negative HBsAb, HBsAg, and HBcAb
* Willing to use acceptable forms of contraception while on study treatment and for 24 weeks after study treatment has ended
Exclusion Criteria for All Participants:
* Cancer. Participants with squamous cell or basal cell skin cancer are not excluded.
* Autoimmune disease
* Immunosuppressive medications. People who use or have used corticosteroid nasal sprays are not excluded. People who have received fewer than 2 weeks of systemic corticosteroids with the last dose over a month prior to study entry are not excluded.
* Any medical or psychiatric condition or occupational responsibilities that may interfere with the study
* Immunomodulator or investigational agent therapy within 30 days prior to study entry
* Allergy/sensitivity to study drugs or their formulations, including thimerosal
* Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study
* Active hepatitis C virus infection, as indicated by serum antibodies to HCV AND detectable HCV RNA in plasma
* Blood clotting abnormalities
* Any other condition that, in the opinion of the investigator, might interfere with the study
* Pregnancy or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00100633
Study Brief:
Protocol Section:
NCT00100633