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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00058734
Eligibility Criteria:
Inclusion Criteria:
Both HIV infected and HIV uninfected individuals are eligible for this study.
* CD4 cell count of 400 cells/mm3 or greater at study entry
* If HIV infected, initiated anti-HIV medicines within 120 days of infection
* If HIV infected, HIV viral load \< 50 copies/ml for at least 3 months prior to study entry
* Current medication regimen for at least 3 months prior to study entry
* A particular blood type (HLA-A\*0201)
* Acceptable methods of contraception
Exclusion Criteria:
* Received investigational drug or vaccine within 30 days prior to study entry
* On other immune-based therapy (e.g., interleukin-2, alpha interferon, immunoglobulin, thalidomide) within 30 days prior to study entry
* Megesterol acetate within 30 days prior to study entry
* Immunization within 4 weeks of study entry
* If hepatitis B virus (HBV) uninfected and at high risk for HBV infection, the patient will not be eligible until he or she has completed an HBV vaccine series.
* Unstable or severe medical condition, including active opportunistic infection requiring treatment
* History of Hashimoto's thyroiditis
* Cancer requiring chemotherapy within 6 months prior to study entry
* History of radiation therapy to axillary lymph nodes
* Significant laboratory abnormalities at study entry
* Pregnant or breastfeeding
* History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, scleroderma, mixed connective tissue disorder)
* Allergy to gentamicin, tobramycin, streptomycin, or amikacin
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00058734
Study Brief:
Protocol Section:
NCT00058734