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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04311957
Eligibility Criteria:
Inclusion Criteria:
* The ability and willingness to give informed consent.
* Age ≥18 years
* History of meeting WHO criteria for immunologic or virologic failure after receipt of a first-line treatment regimen for ≥6 months
* Currently receiving a second-line ART regimen including either ATVr or LPVr + 2 NRTIs for ≥6 months
* At least one HIV-1 RNA \<200 copies/mL within 12 months prior to enrollment, and no HIV-1 RNA of at least 200 copies/mL during this period.
* Plasma HIV-1 RNA \<200 copies/mL at Screening Visit.
* eGFR ≥ 50 mL/min according to the MDRD study equation for creatinine clearance
* Hepatic transaminases (AST and ALT) \</=5X upper limit of normal (ULN)
* No active TB
* Women of childbearing age must agree to take reliable contraception
Exclusion Criteria:
* Active World Health Organization Stage 3 or 4 condition
* Treatment with an INSTI in the past
* Gap in care of at least one month in the prior six months
* Current alcohol or substance use judged by investigator to potentially interfere with participant study compliance
* History of poor adherence, that in the opinion of the investigator, would potentially interfere with study compliance
* Pregnant or breastfeeding at screening visit
* Planning to transfer care
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04311957
Study Brief:
Protocol Section:
NCT04311957