ThyroidTHYVINCT03149354
Prevalence of Thyroid Function Abnormalities in HIV-infected Patients
A study testing Assay of TSH, FT3 and FT4 by immuno-radiometric method in people with Thyroid and HIV Infections, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid, HIV Infections
- What is being tested?
- Assay of TSH, FT3 and FT4 by immuno-radiometric method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2013to 27 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Thyroid Function Abnormalities in HIV-infected Patients: State of Play in 2012
Review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up.
Read the 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.
- Conditions
- Thyroid, HIV Infections
- Being tested
- Assay of TSH, FT3 and FT4 by immuno-radiometric method
- Medical subject headings
- Thyroid Diseases, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assay of TSH, FT3 and FT4 by immuno-radiometric methodOther
Assay of TSH, FT3 and FT4 by immuno-radiometric method Determine the current prevalence of hypothyroidism in HIV-infected patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with HIV | Other | Patients with HIV Receives: Other: Assay of TSH, FT3 and FT4 by immuno-radiometric method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start28 Jan 2013
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel DESAILLOUD, PhD, Principal investigator, CHU AMIENS-PICARDIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149354
- Sponsor's protocol ID
- PI2012_843_0013
- Acronym
- THYVI
- Status last verified
- Jun 2026
- First submitted
- 4 May 2017
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Thyroid Function Abnormalities in HIV-infected Patients: State of Play in 2012
- ClinicalTrials.gov ID
- NCT03149354
- Acronym / sponsor ID
- THYVI / PI2012_843_0013
- Conditions
- Thyroid, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 28 Jan 2013 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HIV | Other | Other: Assay of TSH, FT3 and FT4 by immuno-radiometric methodPatients with HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assay of TSH, FT3 and FT4 by immuno-radiometric methodAssay of TSH, FT3 and FT4 by immuno-radiometric method Determine the current prevalence of hypothyroidism in HIV-infected patients | Other | Patients with HIV |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel DESAILLOUD, PhD principal investigator
CHU AMIENS-PICARDIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assay of TSH, FT3 and FT4 by immuno-radiometric method in people with Thyroid and HIV Infections, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the current prevalence of hypothyroidism (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.