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:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT02665559
Eligibility Criteria:
Inclusion Criteria:
* Men aged 18-50 years at the inclusion visit
* Under antiretroviral treatment for more than six months with undetectable viral load (last sample older than four months before the visit of run)
* Infection by HIV-1 positive (confirmation by a full Western blot or by measurement of plasma HIV RNA prior to the inclusion)
* Lack of co-infections HBV, HCV (last negative serology older than 6 months before the screening visit inclusion)
* Consent signed by the patient and the investigator the day of the inclusion and before any examination required by the test (Article L1122-1-1 the Code of Public Health)
* Patient affiliated or beneficiary of a social security system of the European Community member countries (Article L1121-11 of the Code of Public Health).
Exclusion Criteria:
* Infection by HIV-2
* All stages of cirrhosis
* Severe renal impairment (creatinine clearance below 30 ml / min)
* Opportunistic infection during treatment or opportunistic infection in history
* Neoplastic pathology being processed
* Taken in the previous 3 months of testosterone and other anabolic agents, antiandrogens, estrogens, glucocorticoids, analog GnRH, growth hormone or human insulin-like growth factor-1 (IGF-1)
* Pituitary, adrenal or testicular pathologies , treated or not
* Presence or history of psychotic disorder and / or high suicide risk
* Refusal to participate
* No one under safeguard justice
* Patients participating in another research evaluating other treatments and including an exclusion period ongoing at the inclusion
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02665559
Study Brief:
Protocol Section:
NCT02665559