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Gonadal Function in Young to Middle Aged HIV-infected Men

Sponsor
Azienda Ospedaliero-Universitaria di Modena (Other)
Overall Status
Completed
CT.gov ID
NCT03747003
Collaborator
(none)
315
Enrollment
1
Location
67.5
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Dec 31, 2017
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Serum total testosterone [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 [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 [Calculated only once at the moment of enrollment]

    Calculated formula (Vermeulen equation)

  2. Score at IIEF questionnaire [Assessed only once at the moment of enrollment]

    Total score at erectile function domain of IIEF-15 questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Azienda Ospedaliero - Universitaria di Modena Modena Italy 41124

Sponsors and Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vincenzo Rochira, Associate Professor, Azienda Ospedaliero-Universitaria di Modena
ClinicalTrials.gov Identifier:
NCT03747003
Other Study ID Numbers:
  • 15/13
First Posted:
Nov 20, 2018
Last Update Posted:
Feb 9, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Erectile Dysfunction
Hypogonadism
Eunuchism

Study Results

No Results Posted as of Feb 9, 2021