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

Transversal Study, Prospective, to Evaluate the Prevalence and Factors Associated 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.

Study Overview

• Status: Completed
• Conditions: HIV; Hypogonadism

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Tourcoing, France, 59208
    • Tourcoing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

HIV-infected men, treated by cART and presenting an undetectable viral load

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hypogonadism group; a cross-sectional and prospective study, in HIV-infected men less than 50 years old, with HIV-RNA ≤ 50 cop/mL under ART who had never presented AIDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testosteron Level	Quantification of testosteron level at Day 0 of the inclusion and at Day 8 after inclusion	up to 1 year

Collaborators and Investigators

• Sponsor: Tourcoing Hospital
• Investigators: Study Chair: Antoine CHERET, M.D.,PhD., Tourcoing Hospital; Study Director: Armelle PASQUET, M.D., Tourcoing Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Depression; HIV; Hypogonadism; Reservoirs; Metabolic Syndrom; Osteodensitometry; Erectil dysfonction
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism
• Other Study ID Numbers: HYPOGONADISME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data are reported on a informatic folder centralized at Tourcoing Hospital with anonymous number for each patient Each patient receive by their own practician the biologics data