Gonadal Function in Young to Middle Aged HIV-infected Men

Completed

• Conditions: Human Immunodeficiency Virus; Erectile Dysfunction; Hypogonadism, Male
• Interventions: Other: No intervention is provided

• Registration Number: NCT03747003
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Modena

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2013-05-15
• Primary Completion: 2017-12-31
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Study Completion: 2018-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 315

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Serum total testosterone	Assessed only once at the moment of enrollment with chemiluminiscent immunoassay	From blood sample - unit of measurement ng/dL

Secondary Outcome Measures

Name	Time	Method
Serum free testosterone	Calculated only once at the moment of enrollment	Calculated formula (Vermeulen equation)
Score at IIEF questionnaire	Assessed only once at the moment of enrollment	Total score at erectile function domain of IIEF-15 questionnaire

Trial Locations

Locations (1)

Azienda Ospedaliero - Universitaria di Modena; 🇮🇹 Modena, Italy