Study of the Prevalence and Associated Factors With Hypogonadism in HIV + Men

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.

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Key information

Conditions

Hypogonadism Behavior Behavioral Symptoms Depression Endocrine System Diseases Gonadal Disorders HIV

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Tourcoing Hospital

Tourcoing, 59208, France

About this study

Assess the prevalence and clinical, biological, paraclinical and therapeutic factors associated with primary or secondary hypogonadism in HIV treated and virologically suppressed patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Testosteron Level

Time frame: up to 1 year

Quantification of testosteron level at Day 0 of the inclusion and at Day 8 after inclusion

Sponsors and collaborators

Lead sponsor

Tourcoing Hospital

Other

Registry information

Official study title

Transversal Study, Prospective, to Evaluate the Prevalence and Factors Associated With Hypogonadism in HIV + Men

Acronym: HYPOG

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2018
First posted: Jan 27, 2016
Registry last updated: Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed