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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT02596334
Eligibility Criteria:
Inclusion Criteria:
* HIV-1-infected patients with no previous AIDS event (excluding a healed tuberculosis);
* Current antiretroviral treatment associating dolutegravir + abacavir + lamivudine for at least 1 month;
* Nadir CD4 ≥ 100/mm3;
* Plasma RNA viral load \< 50 copies/ml for at least 12 months;
* Plasma RNA viral load \<20 or 40 copies/ml (according to the threshold of the method used by local laboratory) at the screening visit;
* No documented virologic failure or known resistance to any integrase inhibitor,
* Patient having provided a written consent;
* Patients follow-up possible in ambulatory;
* Patient age \> 18 years;
* Covered by health insurance
Exclusion Criteria:
* Non-compliant patient
* Subject is pregnant, or lactating, or of childbearing potential and without contraception;
* Active opportunistic infections (defining AIDS);
* Known hypersensibility to abacavir or lamivudine or dolutegravir;
* Patients harboring HLA B\*5701;
* Major overweight (BMI ≥ 40);
* Weight \<40 kg;
* Creatinine clearance \< 50ml/min;
* Cirrhosis or severe liver failure (factor V \< 50%);
* Life Prognosis threatened within 6 months;
* Circumstances that may impair judgment or understanding of the information given to the patient;
* Co-medication with carbamazepin, oxcarbamazepin, fosphenytoïn, phenobarbital, phenytoïn, primidon, St John's wort or dofetilid;
* Malabsorption syndromes;
* The following laboratory criteria:
* Serum AST,ALT \> 5 x upper limit of normal (ULN)
* Thrombocytopenia with platelet count \< 50.000/ml
* Anemia with hemoglobin \< 8g/dl
* Polynuclear neutrophil count \< 500/mm3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02596334
Study Brief:
Protocol Section:
NCT02596334