Association Between Human Immunodeficiency Virus (HIV) In... | NCT04760574

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

NCT04760574

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Mar 3, 2021Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Hypogonadism; Ovarian

Interventions

Testosterone

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2021Actual

Primary Completion Date

Nov 2030Estimated

Completion Date

Nov 2030Estimated

First Submitted Date

Feb 16, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case group		HIV infected men who have sex with men	Diagnostic Test: Testosterone
Control group		HIV non-infected men	Diagnostic Test: Testosterone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testosterone	Diagnostic Test	Serum total testosterone and free testosterone level	Case group Control group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shyang-Rong Shih, Ph.D.	Contact	+886-2-2312-3456	61613	srshih@ntu.edu.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D007006	Hypogonadism

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided