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

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ClinicalTrials.gov Identifier: NCT03149354
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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

Condition or disease Intervention/treatment Phase
Thyroid HIV Infections Other: Assay of TSH, FT3 and FT4 by immuno-radiometric method Not Applicable

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 In addition, clinical evidence suggests that dysthyroids may be corrected or worsened over time in HIV patients (unpublished personal data).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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prevalence of Thyroid Function Abnormalities in HIV-infected Patients: State of Play in 2012
Actual Study Start Date : December 19, 2012
Estimated Primary Completion Date : December 19, 2022
Estimated Study Completion Date : December 19, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients with HIV
Patients with HIV
Other: 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




Primary Outcome Measures :
  1. Determine the current prevalence of hypothyroidism [ Time Frame: 10 years ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149354


Contacts
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Contact: Rachel DESAILLOUD, PhD +33322455897 desailloud.rachel@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Rachel DESAILLOUD, PhD    +33322455897    desailloud.rachel@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Rachel DESAILLOUD, PhD CHU AMIENS-PICARDIE
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03149354    
Other Study ID Numbers: PI2012_843_0013
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases