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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04760574
• Collaborator: (none)
• Enrollment: 1,200
• Location: 1
• Anticipated Duration (Months): 116.9
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism; Ovarian	Diagnostic Test: Testosterone

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Association Between Human Immunodeficiency Virus (HIV) Infection and Male Hypogonadism
• Actual Study Start Date: Feb 2, 2021
• Anticipated Primary Completion Date: Nov 1, 2030
• Anticipated Study Completion Date: Nov 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Case group HIV infected men who have sex with men	Diagnostic Test: Testosterone; Serum total testosterone and free testosterone level
Control group HIV non-infected men	Diagnostic Test: Testosterone; Serum total testosterone and free testosterone level

Outcome Measures

Primary Outcome Measures

1. 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

2. Serum free testosterone [2021-2030]

   We use serum free testosterone to study the prevalence of hypogonadism in HIV-infected MSM population

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT04760574
• Other Study ID Numbers: 202010105RIND
• First Posted: Feb 18, 2021
• Last Update Posted: Mar 3, 2021
• Last Verified: Feb 1, 2021

• 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; Hypogonadism; Testosterone

Study Results

No Results Posted as of Mar 3, 2021