Eligibility Module

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 @ 11:38 PM
Ignite Modification Date: 2025-12-24 @ 11:38 PM
NCT ID: NCT00001651
Eligibility Criteria: * INCLUSION CRITERIA: FOR PATIENTS: 18 years or older. Able to provide informed consent and willing to comply with study requirements and clinic policies. Negative urine pregnancy test (for women of childbearing potential). Hemoglobin greater than 10 mg/dl. Adequate venous access in the arms for blood drawing and 5 day infusions, and lymphapheresis Willingness to allow stored samples to be used for future studies of HIV infection and/or immunological function, and willingness to have HLA typing performed. (For previously enrolled patients, patients would be requested, but not required, to provide permission to use stored samples in the future, and to permit HLA testing FOR HIV POSITIVE PATIENTS: Documented HIV infection (ELISA/Western blot positive or, for acute seroconverters, PCR positive). FOR HIV NEGATIVE PATIENTS: Negative ELISA/Western blot. EXCLUSION CRITERIA: Diabetes mellitus requiring drug therapy. Active substance abuse or prior history of substance abuse which may interfere with protocol compliance. Psychiatric illness or disturbance which, in the assessment of the protocol team, may affect patient safety or compliance. Significant underlying cardiac, pulmonary, renal, gastrointestinal, rheumatologic or CNS disease as detectable on routine history, physical exam, or screening laboratory studies. Patients would be excluded if they had an acute or chronic underlying medical problem that in the judgment of the principal investigator could be exacerbated by participating in the protocol or that would make it difficult for them to comply with the protocol requirements. Pregnancy or breast-feeding.
Healthy Volunteers: True
Sex: ALL
Minimum Age: 18 Years
Study: NCT00001651
Study Brief:
Protocol Section: NCT00001651