Gonadal Function in Young to Middle Aged HIV-infected Men

NCT03747003 | Completed

• 1 other identifier: 15/13
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus; Hypogonadism, Male; Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Serum free testosterone

  Calculated only once at the moment of enrollment

• Score at IIEF questionnaire

  Assessed only once at the moment of enrollment

Study Arms (1)

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

Interventions

No intervention is provided OTHER

No intervention is provided

HIV-infected male patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Azienda Ospedaliero - Universitaria di Modena

Modena, 41124, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for hormonal assay

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Eunuchism; Erectile Dysfunction

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hypogonadism; Gonadal Disorders; Endocrine System Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 20, 2018
• Study Start: May 15, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)