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 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT02150993
Eligibility Criteria:
Inclusion Criteria:
* Infection by HIV-2 only;
* Age \> ou = 18 years;
* Naïve for antiretroviral therapy (including antiretroviral treatment in the context of PMTCT except taking a dose of Nevirapine for PMTCT)
* CD4 \>200 cells/mm3
* Resident of the city where the study is held or of city suburbs to facilitate participation
* Signed informed consent document
Exclusion Criteria:
* Current participation in any other clinical trial
* Presence of opportunistic non-stabilized infections, of any serious or progressive disease, or of any clinical signs consistent with severe disease whose diagnosis is not yet confirmed, such as fever, weight loss, diarrhea or cough not yet explained (non-exhaustive list).
* All pathology that leads in daily life to prefer one or the other of the three therapeutic regimens for medical reasons or to change the dosages specified in the test. This includes (but not limited to):
* Hemoglobin ≤ 8 g / dL
* Neutrophil count \<500 cells/mm3
* Renal impairment with creatinine clearance \<50mL/mn
* Blood platelet \<50 000 cells/mm3
* Decompensated heart failure
* Hepatic failure Severe (TP\<50% or cytolysis severe (ALAT\> 3x ULN)
* Active TB during treatment with rifampicin
* Taking drugs that interact with the drugs of the clinical trial (as specified in the SPC)
* Pregnancy, breastfeeding or planning to become pregnant during study follow-up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02150993
Study Brief:
Protocol Section:
NCT02150993