Gonadal Function in Young to Middle Aged HIV-infected Men

NCT ID: NCT03747003

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

315 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-15

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Human Immunodeficiency Virus Hypogonadism, Male Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV-infected male patients

Male patients (age 18-50 years) with HIV-infection and ongoing HAART therapy No intervention is provided

No intervention is provided

Intervention Type OTHER

No intervention is provided

Interventions

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No intervention is provided

No intervention is provided

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Rochira

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliero - Universitaria di Modena

Modena, , Italy

Site Status

Countries

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Italy

Other Identifiers

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15/13

Identifier Type: -

Identifier Source: org_study_id

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