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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00009256
Eligibility Criteria:
* INCLUSION CRITERIA:
HIV infection documented by ELISA/WB.
Viral load documented in our clinic as greater than or equal to 1000 copies RNA/ml plasma on one occasion.
At least 18 years of age.
For women of child-bearing potential, a negative serum pregnancy test is required within 14 days prior to enrollment.
Able to provide written informed consent.
EXCLUSION CRITERIA:
Absence of HIV infection within 8 weeks prior to entry, documented as a negative HIV ELISA and WB within 8 weeks of screening positive ELISA and WB.
Use of immunosuppressants or cytotoxic agents, with the exception of corticosteroids.
Presence of active AIDS defining opportunistic infection or malignancy requiring cytotoxic chemotherapy. Malignancies which do not require systemic cytotoxic chemotherapy, such as low grade non-progressive KS, or skin cancer treated with excision are not exclusion criteria.
Prior antiretroviral therapy with nucleoside or non-nucleoside RT inhibitors or protease inhibitors defined as: any therapy in the last 5 years; any more than 4 days of protease inhibitors or NNRTIs ever taken; any more than 2 weeks of NRTIs ever taken.
Psychiatric illness that in the opinion of the PI might interfere with study compliance.
Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.
Refusal to practice safer sex practices or use precautions to prevent pregnancy (effective barrier birth control or abstinence).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00009256
Study Brief:
Protocol Section:
NCT00009256