Gonadal Function in Young to Middle Aged HIV-infected Men

Azienda Ospedaliero-Universitaria di Modena

Status: Completed

Conditions: Human Immunodeficiency Virus; Erectile Dysfunction; Hypogonadism, Male

Treatments: Other: No intervention is provided

Study type: Observational

Funder types: Other

Identifiers

NCT03747003

15/13

Details and patient eligibility

About

HIV infection is associated to premature decline of serum testosterone. However, prevalence and biochemical characterization of hypogonadism in HIV-infected men are still to be well defined. HIV-infection is strongly associated to erectile dysfunction in men, but preliminary data suggest that it is poorly associated with serum testosterone in this context.

Full description

The aim of this study is to evaluate the gonadal function of young to middle aged HIV-infected men in order to characterize hypogonadism by assessing circulating total testosterone with either Liquid Chromatography tandem Mass Spectrometry (LC-MS/MS) or chemiluminescent immunoassay. Furthermore, secondary aim is to assess the erectile function through the use of validated questionnaires (International Index of Erectile Function (IIEF) 15 and 5).

Enrollment: 315 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male gender
• Age 18-50 years
• HIV-infection
• Ongoing Highly Active Antiretroviral Therapy

Exclusion criteria

• Previous treatment with androgens, anti-androgens
• Severe liver insufficiency
• Severe renal insufficiency

Trial design

315 participants in 1 patient group

HIV-infected male patients

Description:

Male patients (age 18-50 years) with HIV-infection and ongoing HAART therapy No intervention is provided

Treatment:

Other: No intervention is provided