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Completed

NCT Number: NCT03747003

Gonadal Function in Young to Middle Aged HIV-infected Men

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Azienda Ospedaliero - Universitaria di Modena

Modena, 41124, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention is provided

Other

No intervention is provided

Primary outcomes

  1. Serum total testosterone

    Time frame: Assessed only once at the moment of enrollment with liquid chromatography tandem mass spectrometry

    From blood sample - unit of measurement ng/dL

  2. Serum total testosterone

    Time frame: Assessed only once at the moment of enrollment with chemiluminiscent immunoassay

    From blood sample - unit of measurement ng/dL

Secondary outcomes

  1. Serum free testosterone

    Time frame: Calculated only once at the moment of enrollment

    Calculated formula (Vermeulen equation)

  2. Score at IIEF questionnaire

    Time frame: Assessed only once at the moment of enrollment

    Total score at erectile function domain of IIEF-15 questionnaire

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Modena

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Nov 20, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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