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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT00135395
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥ 18 years of age infected with HIV
* Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
* Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
* The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA \< 400 c/mL)
Exclusion Criteria:
* Pregnancy or breastfeeding
* Reported virologic failure to two or more antiretroviral regimens
* Active AIDS-defined opportunistic infection or disease
* Proven or suspected acute hepatitis within 30 days prior to study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00135395
Study Brief:
Protocol Section:
NCT00135395