NCT07552038

Brief Summary

Dental care for people living with HIV has evolved with the widespread use of antiretroviral therapy, which has improved life expectancy and disease control. However, uncertainty remains about whether specific adaptations are still needed during dental procedures due to potential biological abnormalities that may increase infectious or bleeding risks. This study aims to evaluate the proportion of patients living with HIV in the Pays de la Loire region who may require adapted dental management based on biological parameters such as immune status, hematological values, and comorbidities. A retrospective descriptive study will be conducted using anonymized data from 5,603 patients followed in the COREVIH Pays de la Loire database. The results are expected to provide objective data to better inform dental practice and reduce unnecessary precautions or stigmatization in the management of patients living with HIV.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
5,603

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
May 2026May 2026

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

May 2, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

28 days

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Requiring Adapted Dental Management

    Percentage of patients living with HIV presenting at least one biological abnormality associated with increased risk of infectious or hemorrhagic complications during invasive dental procedures, including low CD4 count, neutropenia, thrombocytopenia, or anemia, based on routinely collected clinical data.

    At time of data extraction (retrospective baseline)

Secondary Outcomes (6)

  • CD4 Cell Count Distribution

    At time of data extraction (retrospective baseline)

  • Neutrophil Count Distribution

    At time of data extraction (retrospective baseline)

  • Platelet Count Distribution

    At time of data extraction (retrospective baseline)

  • Hemoglobin Level Distribution

    At time of data extraction (retrospective baseline)

  • Prevalence of Comorbidities

    At time of data extraction (retrospective baseline)

  • +1 more secondary outcomes

Study Arms (1)

Patients With HIV

Patients living with HIV included in a retrospective cohort using anonymized data from the COREVIH Pays de la Loire database. The study population includes adults followed in routine clinical care, with available demographic, clinical, biological, and comorbidity data used to assess factors relevant to dental management.

Other: HIV infection status and clinical characteristics

Interventions

Observational assessment of clinical, biological, and comorbidity data in patients living with HIV, including CD4 count, viral load, hematological parameters, and associated conditions, collected from routine care without any intervention.

Patients With HIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients living with HIV followed in hospital-based infectious diseases departments in France, identified retrospectively from routine clinical records and biological databases.

You may qualify if:

  • Adult patients aged ≥18 years
  • Confirmed diagnosis of HIV infection
  • Followed at participating hospital centers
  • Available clinical and biological data relevant to dental care management (CD4 count, viral load, blood count)

You may not qualify if:

  • Patients with missing key biological data required for analysis
  • Patients not followed in participating centers
  • Patients with incomplete medical records preventing assessment of outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Gilles Amador del Valle, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04