NCT03149354

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2012

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

10 years

First QC Date

May 4, 2017

Last Update Submit

August 3, 2018

Conditions

ThyroidHIV Infections

Outcome Measures

Primary Outcomes (1)

  • 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

    10 years

Study Arms (1)

Patients with HIV

OTHER

Patients with HIV

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

Interventions

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

Patients with HIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Thyroid DiseasesHIV Infections

Condition Hierarchy (Ancestors)

Endocrine System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Rachel DESAILLOUD, PhD

    CHU AMIENS-PICARDIE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel DESAILLOUD, PhD

CONTACT

+33322455897desailloud.rachel@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 11, 2017

Study Start

December 19, 2012

Primary Completion

December 19, 2022

Study Completion

December 19, 2022

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

FR(1)