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

March 1, 2021 updated by: National Taiwan University Hospital
Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shyang-Rong Shih, Ph.D.
  • Phone Number: 61613 +886-2-2312-3456
  • Email: srshih@ntu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Shyang-Rong Shih, Ph.D.
          • Phone Number: 61613 +886-2-2312-3456
          • Email: srshih@ntu.edu.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Cross-sectional study investigating the prevalence of hypogonadism in HIV-infected MSM population. Age-matched non-HIV infected group will be used as comparison group

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms of androgen deficiency
Time Frame: 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
2021-2030
Serum free testosterone
Time Frame: 2021-2030
We use serum free testosterone to study the prevalence of hypogonadism in HIV-infected MSM population
2021-2030

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Anticipated)

November 1, 2030

Study Completion (Anticipated)

November 1, 2030

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202010105RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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