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

HIV Clinical Trial

— HYPOG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665559
• Other study ID #: HYPOGONADISME
• Status: Completed
• Start date: January 2013
• Est. completion date: March 31, 2018

Study information

• Verified date: January 2016
• Source: Tourcoing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 31, 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Hypogonadism

Locations

Country	Name	City	State
France	Tourcoing Hospital	Tourcoing

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosteron Level	Quantification of testosteron level at Day 0 of the inclusion and at Day 8 after inclusion	up to 1 year