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:
NCT00006495
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for Step I of this study if they:
* Are at least 18 years old.
* Are HIV-infected.
* Have been on stable anti-HIV combination drug therapy for at least 12 weeks prior to screening for viral load and are willing to continue the same treatment during the study unless they experience side effects from the drugs and have a viral load increase.
* Have a viral load lower than 50 copies/ml at screening. Patients must have had a viral load below 500 copies/ml for at least 12 weeks prior to screening.
* Have a CD4 T cell count of at least 300 cells/mm3 within 30 days prior to study entry.
* Agree to practice acceptable methods of birth control, including male and female condoms, a diaphragm, or an intra-uterine device (IUD), while on study treatment and for 12 weeks after study treatment is discontinued.
* Patients may be eligible for Step II of this study if they:
* Are enrolled in A5058s under A5057/A5058s, Versions 1.0 and 2.0.
Exclusion Criteria
Patients will not be eligible for Step I of this study if they:
* Are pregnant or breast-feeding.
* Have an acute infection requiring antibiotics, an outbreak of a herpes virus, or other illness or surgery within 30 days prior to entry.
* Have a long-term infection other than HIV.
* Have cancer that may require systemic treatment.
* Have had lymph node irradiation.
* Have received any HIV vaccine.
* Have used GM-CSF, G-CSF, M-CSF, IFN, IL-2, or similar medication within 30 days prior to entry.
* Have used drugs affecting the immune system within 30 days prior to entry, or have an illness that may require use of these drugs.
* Have had immunizations within 30 days prior to study entry.
* Have received hydroxyurea within 30 days prior to study entry.
* Are allergic to egg proteins or neomycin or have had other serious allergic reactions.
* Work in close contact with canaries, or react to canarypox. Persons with a pet canary are not excluded.
* Have had 2 viral load measurements in a row taken at least 14 days apart that were 500 copies/ml or higher in the 12 weeks prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006495
Study Brief:
Protocol Section:
NCT00006495