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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00896051
Eligibility Criteria:
Inclusion Criteria:
\- Documented HIV-1 infection
* Failing on a stable ART (anti retroviral therapy) with HIV-1 plasma viral load above 500 HIV-1 RNA copies/ml
* Presence of at least 1 documented NNRTI mutation
* Demonstrated sensitivity to ATV, ETR and at least one of the selected NRTIs based on the resistance test at screening
* General medical condition, in the investigator's opinion, does not interfere with the assessments and completion of the trial
* Substudy: patients who have been treated in C238 for more than 24 weeks and are currently suppressed (defined as patients with at least 2 most recent and consecutive viral loads less than 50 cp/mL) will be considered eligible for the substudy
Exclusion Criteria:
* Primary HIV-1 infection
* Previously documented HIV-2 infection
* Previously failed 2 or more HIV PI-containing regimens
* Previous diagnosis of hereditary hyperbilirubinemia (eg. Gilbert's syndrome, Crigler-Najjar syndrome).
Grade 3 or 4 toxicities (according to DAIDS grading)
* Acute and chronic viral hepatitis
* Receipt of an investigational drug or investigational vaccine within 30 days prior to the trial drug administration
* Pregnant or breastfeeding female
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00896051
Study Brief:
Protocol Section:
NCT00896051