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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT03374358
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent (IC) obtained.
* HIV-positive adult (age over 18) subjects currently on stable ART, with no changes in the ART regimens during the past 6 months.
* Current ART includes either a protease inhibitor or efavirenz.
* No documented or suspected resistance to integrase inhibitors or to NRTIs.
* No prior history of virologic failure. Failure is defined as a confirmed plasma viral load \> 200 cop/ml measured no less than six months after initiation or modification of therapy.
* Virological blips accepted only if a single viral load measurement has been between 50-200 cop/ml followed by viral load \< 50 cop/ml without the need to initiate a change in ART and no blip within 12 month window period prior to screening.
* Documented evidence of at least two HIV viral load \< 50 cop/ml measurements during the past 12 months prior to inclusion: one within 6 months prior to screening.
* HIV viral load \< 50 cop/ml at screening.
* BMI\>25 kg/m2 and one metabolic syndrome condition, which are
* BP ≥ 130/≥ 85 mmHg or hypertension medication currently in use or
* fasting glucose ≥ 5.6 mmol/l or B-HbA1C \> 42 mmol/mol or diabetes medication currently in use or
* HDL \< 1.0 mmol/l in men and \< 1.3 mmol/l in women or triglycerides ≥ 1.7 mmol/l or a cholesterol-lowering regimen currently in use or
* waist circumference \> 94 cm in men and \>80 cm in women (or respective cut off values for non-European ethnic groups as defined by International Diabetes Federation). OR
* ultrasound or biopsy proven hepatosteatosis.
Exclusion Criteria:
* Within 12 month window period prior to screening, HIV viral load measurement of \>50 cop/ml.
* More than one consecutive HIV viral load measurements of \> 50 cop/ml in the treatment history after initial viral suppression with ART.
* Chronic hepatitis B or C.
* Daily alcohol consumption ≥ 30 g for men and ≥ 20 g for women.
* Pregnancy or planned pregnancy during the study period.
* Lipid or glucose lowering regimen or hormonal supplement started within 3 months before the planned study start.
* Psychiatric disorder, which prevents a study subject to understand the study protocol.
* Other serious disease, which prevents a study subject to participate in the study.
* For MRI/spectroscopy imaging: metal objects in the body or claustrophobia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03374358
Study Brief:
Protocol Section:
NCT03374358