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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT02067767
Eligibility Criteria:
Inclusion Criteria:
* Patient with confirmed HIV-1 infection (HIV antibody positive confirmation prior to screening)
* Age ≥ 18 years
* Written informed consent
* Male patient or non-pregnant, non-lactating female patient
* On antiretroviral treatment with nevirapine (400 mg per day) plus abacavir/lamivudine for more than 6 months; Nevirapine 400 mg/day being administered as either 1 x 200 mg IR x 2/day or 2 x 200 mg IR qd or 1 x 400 mg XR qd
* No history of prior virologic failure on antiretroviral therapy
* HIV-1 RNA \< 50 copies/ml for more than 1 year,
* No major IAS-USA nucleoside reverse transcriptase inhibitors or integrase inhibitors resistance mutations on genotypic testing on last plasma sample with HIV-1 RNA \> 500 c/mL (if available)
* HLA-B\*5701 negative test
* Subjects covered by Health Insurance
Exclusion Criteria:
* Woman of child-bearing potential without effective contraception method. Pregnant or breastfeeding woman.
* Woman expecting to conceive during the study period
* HIV-2 co-infection
* Any prior exposure to integrase inhibitor(s)
* Plasma HIV-1 RNA \> 50 c/mL in the past year
* Creatinine clearance \< 60 ml/mn (estimated glomerular filtration rate according to the MDRD equation),
* Alkaline phosphatase, ASAT or ALAT ≥ 5 times the upper limit of the norm (ULN)
* Patient with history of decompensated liver disease
* Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or integrase inhibitors on any historical plasma genotype if available. Any previous genotype result is valid, with no time limit, as long as the original test result is documented.
* Mycobacteriosis under treatment
* Malignancy requiring chemotherapy or radiotherapy
* Positive HBs Ag
* HCV infection for which specific treatment is ongoing or planned during the study
* Known hypersensitivity to one of the trial drugs, the metabolites or formulation excipients
* Concomitant therapy with antacids or H2 antagonists
* Contraindicated concomitant treatment
* Anticipated non-compliance with the protocol
* Participation in another clinical trial with an on-going exclusion period at screening
* Subject under legal guardianship or incapacitation
* Subject, who in the opinion of the investigator, is unable to complete the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02067767
Study Brief:
Protocol Section:
NCT02067767