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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT00000795
Eligibility Criteria:
Inclusion Criteria
Subjects must have:
* Normal history and physical exam.
* HIV negativity by ELISA within 8 weeks of immunization.
* CD4 count \>= 400 cells/mm3.
* Normal urinalysis.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
* Positive hepatitis B surface antigen.
* Medical or psychiatric condition or occupational responsibilities that preclude study compliance.
* Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
* Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
Subjects with the following prior conditions are excluded:
* History of immunodeficiency, chronic illness, or autoimmune disease.
* History of anaphylaxis or other serious reactions to vaccines.
Prior Medication:
Excluded:
* History of immunosuppressive medications.
* Live attenuated vaccines within 60 days prior to study entry (NOTE: Medically indicated subunit or killed vaccines, e.g., influenza or pneumococcal, are not exclusionary, but should not be given within 2 weeks of HIV immunization).
* Experimental agents within 30 days prior to study entry.
* Prior HIV vaccines.
Prior Treatment:
Excluded:
* Blood products or immunoglobulin within the past 6 months.
Identifiable higher risk behavior for HIV infection, including the following:
* History of injection drug use within the past 12 months.
* Higher risk sexual behavior as defined by the AVEG.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00000795
Study Brief:
Protocol Section:
NCT00000795