Prevalence of Thyroid Function Abnormalities in HIV-infected Patients

NCT ID: NCT03149354

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-19

Study Completion Date

2022-12-19

Brief Summary

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Review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up.

Detailed Description

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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 In addition, clinical evidence suggests that dysthyroids may be corrected or worsened over time in HIV patients (unpublished personal data).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.

Conditions

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Thyroid HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with HIV

Patients with HIV

Group Type OTHER

Assay of TSH, FT3 and FT4 by immuno-radiometric method

Intervention Type OTHER

Assay of TSH, FT3 and FT4 by immuno-radiometric method Determine the current prevalence of hypothyroidism in HIV-infected patients

Interventions

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Assay of TSH, FT3 and FT4 by immuno-radiometric method

Assay of TSH, FT3 and FT4 by immuno-radiometric method Determine the current prevalence of hypothyroidism in HIV-infected patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel DESAILLOUD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS-PICARDIE

Locations

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CHU Amiens Picardie

Amiens, Picardie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Rachel DESAILLOUD, PhD

Role: CONTACT

+33322455897

Facility Contacts

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Rachel DESAILLOUD, PhD

Role: primary

+33322455897

Other Identifiers

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PI2012_843_0013

Identifier Type: -

Identifier Source: org_study_id

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