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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00272493
Eligibility Criteria:
Inclusion Criteria:
* HIV infected
* CD4 count of 200 cells/mm3 or more within 30 days prior to study entry
* HIV-1 RNA viral load value obtained within 30 days prior to study entry
* Received HAART for at least 8 weeks prior to study entry OR not on HAART within 8 weeks prior to study entry with no plans to start HAART during the study. Participants receiving HAART must be on stable therapy as defined by the protocol.
* Negative hepatitis B core total antibody (HBcAb total), qualitative hepatitis B surface antibody (HBsAb), and hepatitis B surface antigen (HBsAg) tests within 30 days prior to study entry
* Negative hepatitis C virus (HCV) antibody test, completed within 30 days prior to study entry
* Willing to use acceptable forms of contraception
Exclusion Criteria:
* HCV antibody or HCV RNA positive at any time prior to study entry
* Previously vaccinated against HBV
* Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, vaccines, interleukins, interferons, growth factors, or intravenous immune globulin within 30 days prior to study entry
* Known allergy or sensitivity to any component of the study drugs
* Active drug or alcohol dependence that would interfere with participation in the study
* Any mental illness that may interfere with the study
* Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
* Body weight less than 50 kg (110 lbs)
* Abnormal lab values
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00272493
Study Brief:
Protocol Section:
NCT00272493