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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00005758
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are HIV-positive.
* Have been on certain anti-HIV drugs for at least 3 months and intend to continue the same anti-HIV drugs unless they develop side effects to the drugs or their viral load rises above a certain level.
* Have a viral load of less than 500 copies/ml for at least 3 months before entering the study.
* Have a CD4 count of at least 300 cells/mm3.
* Are at least 14 years old (consent of parent or guardian required if under 18).
* Agree to practice barrier methods of birth control (such as condoms) while on the study and for 3 months after the study ends.
* Patients may be eligible for the substudy if they:
* Are at least 18 years old.
* Have a plasma HIV viral load below 50 copies/ml.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Are pregnant or breast-feeding.
* Have had an infection requiring antibiotics, an outbreak of herpes simplex virus (HSV) or herpes zoster, or other illness or surgery within 30 days of study entry. (This study has been changed to exclude patients who have had an outbreak of HSV or herpes zoster or have had surgery within 30 days of study entry.)
* Currently have any long-term infection other than HIV.
* Have cancer that requires chemotherapy.
* Have had lymph node irradiation.
* Have ever received an HIV vaccine.
* Have taken certain drugs affecting the immune system within 30 days of study entry.
* Have taken hydroxyurea within 30 days of study entry.
* Have received any vaccine within 30 days of study entry.
* Patients will not be eligible for the substudy if they:
* Have a history of allergies to egg proteins or neomycin, or a history of other serious allergic reactions.
* Ever worked closely with canaries in a bird shop or breeding farm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00005758
Study Brief:
Protocol Section:
NCT00005758