Gonadal Function in Young to Middle Aged HIV-infected Men

Gonadal Function in Young to Middle Aged HIV-infected Men Assessed by Isotopic Dilution-liquid Chromatography-mass Spectrometry (ID-LC-MS/MS) and Chemiluminescent Immunoassay

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Human Immunodeficiency Virus; Hypogonadism, Male
• Intervention / Treatment: Other: No intervention is provided

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 Type: Observational
• Enrollment (Actual): 315

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy, 41124
    • Azienda Ospedaliero - Universitaria di Modena

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

Cohort of Young-to-Middle Aged HIV-infected Patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HIV-infected male patients; Male patients (age 18-50 years) with HIV-infection and ongoing HAART therapy No intervention is provided	Other: No intervention is provided; No intervention is provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum total testosterone	From blood sample - unit of measurement ng/dL	Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry
Serum total testosterone	From blood sample - unit of measurement ng/dL	Assessed only once at the moment of enrollment with chemiluminiscent immunoassay

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Modena

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2013
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Endocrine System Diseases; Gonadal Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Slow Virus Diseases; HIV Infections; Erectile Dysfunction; Acquired Immunodeficiency Syndrome; Hypogonadism; Eunuchism
• Other Study ID Numbers: 15/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No