Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism

Recruiting

• Conditions: Hypogonadism; Ovarian
• Interventions: Diagnostic Test: Testosterone

• Registration Number: NCT04760574
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population

Detailed Description

In this study, we conduct a cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected MSM group will be used as comparison group. We will also determine the risk factors associated with male hypogonadism (age, duration of HIV infection, comorbidities, BMI, ART use). Correlation will be made between serum testosterone levels and sexual function, vitality, exercise capacity, mood, and bone mineral density.

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02-02
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-18
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03
• Primary Completion: 2030-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1200

Inclusion Criteria

• HIV-infected men who have sex with men
• HIV non-infected men

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Exclusion Criteria

• Use of testosterone supplement, anabolic steroid in the past one year.
• History of pituitary , adrenal or gonad diseases
• History of pituitary surgery or radiation therapy
• History of systemic chemotherapy
• Active opportunistic infection under treatment
• Cancer
• Severe hepatic, renal or cardiac impairment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	Testosterone	HIV infected men who have sex with men
Control group	Testosterone	HIV non-infected men

Primary Outcome Measures

Name	Time	Method
Serum free testosterone	2021-2030	We use serum free testosterone to study the prevalence of hypogonadism in HIV-infected MSM population
Symptoms of androgen deficiency	2021-2030	We use the score of Androgen Deficiency in Aging Males (ADAM) questionnaire to study the prevalence of hypogonadism in HIV-infected MSM population

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan