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
|Condition or disease||Intervention/treatment||Phase|
|Thyroid HIV Infections||Other: Assay of TSH, FT3 and FT4 by immuno-radiometric method||Not Applicable|
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 In addition, clinical evidence suggests that dysthyroids may be corrected or worsened over time in HIV patients (unpublished personal data).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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149354
|Contact: Rachel DESAILLOUD, PhDemail@example.com|
|CHU Amiens Picardie||Recruiting|
|Amiens, Picardie, France, 80054|
|Contact: Rachel DESAILLOUD, PhD +33322455897 firstname.lastname@example.org|
|Principal Investigator:||Rachel DESAILLOUD, PhD||CHU AMIENS-PICARDIE|