Study of the Prevalence and Associated Factors With Hypogonadism in HIV + Men (NCT02665559) | Clinical Trial Compass
CompletedNot Applicable
Study of the Prevalence and Associated Factors With Hypogonadism in HIV + Men
France250 participantsStarted 2013-01
Plain-language summary
Testosterone deficiency is classically associated with the development of metabolic syndrome, osteoporosis, erectile disorder and / or a reduced libido, a depressive syndrome and alteration of the quality of patients life.
Chronicity of HIV infection leads to several disorders as fever, chronic stress, weight loss and cachexia which are the cause of hypogonadotropic hypogonadism. On the other hand, abnormal secretion of cytokines, secondary to the infection may alter the Leydig cells causing a hypergonadotropic hypogonadism and disrupts steroidogenesis. Cases of testicular invasion by lymphoma or Kaposi's syndromes have also been described.
The advent of antiretroviral therapy has reduced the prevalence of hypogonadism in patients infected with HIV that is currently about 20%. This prevalence remains about 20%, regardless of the antiretroviral therapy and CD4-T cell count.
No study to our knowledge has so far assessed exhaustively the clinical features, biological, therapeutic and paraclinical of hypotestosteronemiae while assessing the level of total serum testosterone, SHBG and serum free testosterone, among HIV infected patients in the European population.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.