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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02384967
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infected adults,
* age ≥ 18 years,
* with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (≥ 6 months),
* virologically controlled (VL ≤ 50 cp/ml,
* ≥ 1 year,
* at least 2 VL spaced at least 3 months apart in the last 12 months) CD4 count ≥ 300/mm3 ≥ 6 months,
* virus sensible to darunavir and the used NRTI (pretreatment resistance genotypic test available) and
* with no history of virological failure (VL \> 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
* no current opportunistic infection,
* renal clearance ≥ 60 mL/min if tenofovir is used,
* transaminases (SGOT, SGPT) plasma levels \< 2N,
* hemoglobin \> 11 g/dL,
* platelets count \> 150 000/mm3,
* negative pregnancy test in women with childbearing potential,
* informed written consent signed by both the investigator and the subject,
* national insurance scheme (article L1121-11 of the French Public Health code),
* no participation to any other clinical trial
Exclusion Criteria:
* HIV-2 infection,
* current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI,
* virus genotypically resistant to darunavir and the used NRTIs,
* history of virological failure (VL \> 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
* irregular follow-up and/or history of lack of adherence to ART ≤ 12 months,
* current pregnancy,
* current opportunistic infection,
* associated treatment containing one or more drugs interacting with hepatic cytochromes,
* any addictive behaviors (alcohol consumption, drugs …) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02384967
Study Brief:
Protocol Section:
NCT02384967