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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00002350
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Low doses of nonprescription NSAIDS, acetaminophen, ibuprofen, aspirin, replacement hormone therapy, and vitamin supplements.
Patients must have:
* Asymptomatic HIV infection with no acute related infection.
* CD4 count \>= 500 cells/mm3.
* Normal hematologic, renal, hepatic, metabolic, and endocrine function.
NOTE:
* No more than one patient over 50 years of age is permitted at each dose level.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Residual toxicity from prior drug treatment.
* Hypersensitivity to bupivacaine or amide-type local anesthetic.
* Active viral hepatitis, autoimmune disorders, or other debilitating chronic diseases.
Concurrent Medication:
Excluded:
* Medications that affect immune function.
* Antiretrovirals.
Patients with the following prior conditions are excluded:
* Malignancies other than curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* History of anaphylaxis to vaccines.
Prior Medication:
Excluded:
* Prior immunization with any experimental HIV vaccines.
* Other experimental therapy within 30 days prior to study entry.
* Prior cancer chemotherapy.
* Antiretrovirals within 3 months prior to study entry.
Prior Treatment:
Excluded:
* Prior radiotherapy. IV drug use or any other high-risk behavior.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002350
Study Brief:
Protocol Section:
NCT00002350