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Gonadal Function in Young to Middle Aged HIV-infected Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03747003
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena

Study Description
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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.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Hypogonadism, Male Erectile Dysfunction 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 Design
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Study Type : Observational
Actual Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : May 15, 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Blood sample for hormonal assay

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cohort of Young-to-Middle Aged HIV-infected Patients
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747003


Locations
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Italy
Azienda Ospedaliero - Universitaria di Modena
Modena, Italy, 41124
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Modena
More Information
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Responsible Party: Vincenzo Rochira, Associate Professor, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier: NCT03747003    
Other Study ID Numbers: 15/13
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Erectile Dysfunction
Hypogonadism
Eunuchism
Immunologic Deficiency Syndromes
Immune System Diseases
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
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Gonadal Disorders
Endocrine System Diseases