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

Hypogonadism; Ovarian Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760574
• Other study ID #: 202010105RIND
• Status: Recruiting
• Start date: February 2, 2021
• Est. completion date: November 2030

Study information

• Verified date: February 2021
• Source: National Taiwan University Hospital
• Contact: Shyang-Rong Shih, Ph.D.
• Phone: +886-2-2312-3456
• Email: srshih[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 2030
• Est. primary completion date: November 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• HIV-infected men who have sex with men

• HIV non-infected men

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Hypogonadism
• Hypogonadism; Ovarian

Intervention

Diagnostic Test:
• Testosterone
Serum total testosterone and free testosterone level

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of androgen deficiency	We use the score of Androgen Deficiency in Aging Males (ADAM) questionnaire to study the prevalence of hypogonadism in HIV-infected MSM population	2021-2030
Primary	Serum free testosterone	We use serum free testosterone to study the prevalence of hypogonadism in HIV-infected MSM population	2021-2030