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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00001060
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Other medically indicated vaccinations, provided they are administered at least 2 weeks before or after any study injection.
* Alcohol use limited to 1 oz per day of 100 proof.
Patients must have:
* HIV infection without evidence of AIDS.
* CD4 count \> 500 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Current evidence of underlying lung or liver disease.
* Suspected or diagnosed allergy to any vaccine component.
* Medical contraindication to protocol participation.
* Undergoing allergy skin testing or desensitization.
Concurrent Medication:
Excluded:
* Antiretroviral therapy (unless clinically indicated and with approval of investigator).
* Immunosuppressive or immunomodulatory therapy.
* Nonsteroidal anti-inflammatory agents (except short-term therapy for acute conditions).
* Drugs with known hepatotoxicity.
* Alcohol intake \> 1 oz per day of 100 proof.
Patients with the following prior conditions are excluded:
* History of underlying lung disease.
* Abnormal chest radiograph within 2 weeks prior to first vaccine injection.
* History of underlying liver disease.
* Abnormal hepatitis B surface antigen or hepatitis C antibody test within 2 weeks prior to first vaccine injection.
* Abnormal liver function tests within 30 days prior to study entry.
* Evidence of uveitis by slit lamp exam within 2 weeks prior to study entry.
* Anergic as evidenced by negative skin test responses to all three antigens in a panel consisting of tetanus toxoid, mumps, and Candida albicans, within 6 weeks prior to first vaccine injection.
* Prior participation on an HIV vaccine trial.
Prior Medication:
Excluded within the past 3 months:
* Antiretroviral therapy.
* Immunosuppressive drugs.
* Alpha interferon or any immunomodulatory drugs.
* Any investigational HIV drugs or therapies. Current alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00001060
Study Brief:
Protocol Section:
NCT00001060