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Prevalence of Thyroid Function Abnormalities in HIV-infected Patients (THYVI)

Primary Purpose

Thyroid, HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assay of TSH, FT3 and FT4 by immuno-radiometric method
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thyroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major Patients.
  • Infected with HIV, regardless of stage of disease and treatment, diagnosed between January 2001 and December 2012
  • Follow-up at the University Hospital of Amiens.

Exclusion Criteria:

  • Patients in the THIVY1 study lost to follow-up since 2001, having moved or undergoing therapeutic break-up
  • Deceased Patients
  • Major protected persons (under guardianship or guardianship)
  • Pregnant women
  • Refusal of participation

Sites / Locations

  • CHU Amiens PicardieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with HIV

Arm Description

Patients with HIV

Outcomes

Primary Outcome Measures

Determine the current prevalence of hypothyroidism
Statistical evaluation of the occurrence of hypothyroidism (clinical and frustrated) in HIV-infected patients Presence or absence of hypothyroidism (clinical and frustration) in patients infected with HIV. Hypothyroidism is defined by TSH> 4mUI / ml and / or FT4 <threshold of normal dosage

Secondary Outcome Measures

Full Information

First Posted
May 4, 2017
Last Updated
August 3, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03149354
Brief Title
Prevalence of Thyroid Function Abnormalities in HIV-infected Patients
Acronym
THYVI
Official Title
Prevalence of Thyroid Function Abnormalities in HIV-infected Patients: State of Play in 2012
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2012 (Actual)
Primary Completion Date
December 19, 2022 (Anticipated)
Study Completion Date
December 19, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up.
Detailed Description
Since the appearance of high-efficiency anti-retrovirals (HAARTs) in the treatment of Human Immunodeficiency Virus (HIV), several studies have shown an increase in the prevalence of hypothyroidism (frank, rough or low hypothyroidism T4) in cohorts of HIV-infected adults and children. More specifically, rough hypothyroidism (increased TSH and normal thyroid peripheral hormones) have a prevalence of about 3-12% in HIV-treated patients, which is higher than the general population of about 4.3%. The etiology of frustrated hypothyroidism remains debated in the literature; Effects of antiretroviral therapy (ARV) such as Stavudine®, the effect of dyslipidemia, the effect of HIV infection itself, in proportion to severity (expressed as low CD4 cell count) and AIDS stage. Thyroid dysfunction does not appear to be of autoimmune origin, as anti-peroxidase antibodies are rarely present in HIV-infected patients, unlike the general population. With the increased life expectancy of HIV-infected patients and the indications of different experts to be treated earlier, the duration of exposure to ARVs is also increasing. Therefore, their chronic toxicity deserves particular attention, in particular on thyroid function and / or thyroid hormone metabolism, since iatrogenicity has not been completely ruled out. In addition, clinical evidence suggests that dysthyroids may be corrected or worsened over time in HIV patients (unpublished personal data). Today, the natural history of frustrated hypothyroidism and its consequences are not reported in patients infected with HIV. However, it is recognized in the elderly, fructified hypothyroidism evolves over time towards frank hypothyroidism; The latter is associated with an increased prevalence of dyslipidemia, atherosclerosis, diastolic hypertension and therefore an increased risk of myocardial infarction. It therefore seems interesting to review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid, HIV Infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with HIV
Arm Type
Other
Arm Description
Patients with HIV
Intervention Type
Other
Intervention Name(s)
Assay of TSH, FT3 and FT4 by immuno-radiometric method
Intervention Description
Assay of TSH, FT3 and FT4 by immuno-radiometric method Determine the current prevalence of hypothyroidism in HIV-infected patients
Primary Outcome Measure Information:
Title
Determine the current prevalence of hypothyroidism
Description
Statistical evaluation of the occurrence of hypothyroidism (clinical and frustrated) in HIV-infected patients Presence or absence of hypothyroidism (clinical and frustration) in patients infected with HIV. Hypothyroidism is defined by TSH> 4mUI / ml and / or FT4 <threshold of normal dosage
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major Patients. Infected with HIV, regardless of stage of disease and treatment, diagnosed between January 2001 and December 2012 Follow-up at the University Hospital of Amiens. Exclusion Criteria: Patients in the THIVY1 study lost to follow-up since 2001, having moved or undergoing therapeutic break-up Deceased Patients Major protected persons (under guardianship or guardianship) Pregnant women Refusal of participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel DESAILLOUD, PhD
Phone
+33322455897
Email
desailloud.rachel@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel DESAILLOUD, PhD
Organizational Affiliation
CHU AMIENS-PICARDIE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel DESAILLOUD, PhD
Phone
+33322455897
Email
desailloud.rachel@chu-amiens.fr

12. IPD Sharing Statement

Learn more about this trial

Prevalence of Thyroid Function Abnormalities in HIV-infected Patients

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