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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02069834
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* HIV-1 infection
* Treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, or 1 NNRTI, or INI), unchanged for \> 6 months, Intra-class substitution within past 6 months is not considered as a treatment change.
* Plasma HIV-RNA ≤ 50 copies/mL for \> 2 years
* CD4 cell count \> 350/mm3 for \> 6 months
* No prior virologic failure under an NNRTI-containing or an INSTI-containing ART regimen
* No NNRTI mutation on pre-ART genotype (if no pre-ART genotype available: no NNRTI mutation on DNA genotype at screening) among the following: K101E/P, E138A/G/K/Q/R/S, V179L, Y181C/I/V, Y188L, H221Y, M230I/L/V, L100I + K103N/S, L100I +K103R +V179D.
* No mutation (either on pre-ART genotype or on DNA genotype at screening) among the following: T66K, G118R, V151L, S153F/Y, R263K, T66K + L74M, E92Q + N155H, Q148R +N155H, Q148H/K/R with at least one mutation of L74I or E138A/K/T or G140A/C/S
* Negative HBs Ag
* Informed consent form signed by patient and investigator
* A specific consent for the pharmacokinetic substudy will be signed by the 10 patients of the pilot phase of the trial who will be randomized to the Dolutegravir + Rilpivirine arm and will volunteer for this PK study
* Patient covered with health insurance
* Effective contraception
Exclusion Criteria:
* HIV-2 infection
* Dialysis or severe renal failure (creatinine clearance \< 30 ml/min)
* History of decompensated liver disease
* History of HIV-associated neurocognitive disorders
* AST or ALT \> 5 x ULN
* Positive HBc Ac and negative HBs Ac
* Patient receiving a proton pump inhibitor that cannot be switched to another anti-secretory drug
* Current pregnancy or breastfeeding
* Patient involved in another research that precludes enrolment in another trial
* Patient under guardianship, or deprived of liberty by a court or administrative decision.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02069834
Study Brief:
Protocol Section:
NCT02069834