HIV InfectionVIH-ODONTONCT07552038
Dental Management of Patients With HIV in Pays de la Loire
An observational study of HIV Infection and Acquired Immune Deficiency Syndrome, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Acquired Immune Deficiency Syndrome, Oral Health Care
- What is being tested?
- HIV infection status and clinical characteristics
- How many people
- 5,603 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- 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)
Who cannot join
- Patients with missing key biological data required for analysis
- Patients not followed in participating centers
- Patients with incomplete medical records preventing assessment of outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes-Department of Dentistry
Nantes, Nantes, 44000
Alexandra Poinas, alexandra.poinas@chu-nantes.fr
About this study
Official title: Dental Management of Patients Living With HIV: A Retrospective Study Using COREVIH Data in Pays de la Loire
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.
Read the detailed description
This is a retrospective descriptive observational study using anonymized data from patients living with HIV followed in the Pays de la Loire region. The dataset includes 5,603 individuals whose data were previously collected as part of routine clinical care and recorded in the Nadis medical database by healthcare professionals involved in HIV management.
Data were provided by the COREVIH Pays de la Loire in an anonymized format and include demographic characteristics (age, sex), HIV-related variables (viral load, duration since diagnosis, antiretroviral therapy status), co-infections (sexually transmitted infections and hepatitis B/C), biological parameters (CD4 lymphocyte count, neutrophil count, platelet count, hemoglobin level), and comorbidities (e.g., diabetes, hypertension, renal disease, cardiovascular conditions, depression).
The primary objective is to determine the proportion of patients presenting biological abnormalities that may increase the risk of infectious or hemorrhagic complications during invasive dental procedures.
Data analysis will consist of descriptive statistics, including frequencies and percentages for categorical variables. The study does not involve any intervention, additional data collection, or direct patient contact.
All data are fully anonymized prior to analysis, ensuring that participants cannot be identified. The study complies with applicable data protection regulations and is based on previously collected clinical data.
- Being tested
- HIV infection status and clinical characteristics
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV infection status and clinical characteristicsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HIV infection status and clinical characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of data extraction (retrospective baseline)
Secondary outcomes (6)
CD4 Cell Count Distribution
CD4 lymphocyte count (cells/mm³) distribution among patients, used to assess immune status. Lower values indicate greater immunosuppression.
Measured: At time of data extraction (retrospective baseline)
Neutrophil Count Distribution
Neutrophil count (cells/mm³) measured from routine blood tests. Lower values indicate increased risk of infection.
Measured: At time of data extraction (retrospective baseline)
Platelet Count Distribution
Platelet count (×10⁹/L) measured from routine blood tests. Lower values indicate increased bleeding risk.
Measured: At time of data extraction (retrospective baseline)
Hemoglobin Level Distribution
Hemoglobin level (g/dL) measured from routine blood tests. Lower values indicate anemia.
Measured: At time of data extraction (retrospective baseline)
Prevalence of Comorbidities
Percentage of patients presenting comorbid conditions (e.g., diabetes, cardiovascular disease, renal disease, depression) that may impact dental management.
Measured: At time of data extraction (retrospective baseline)
Viral Load Status
Proportion of patients with detectable versus undetectable HIV viral load, based on routine clinical measurements.
Measured: At time of data extraction (retrospective baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start2 May 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,603 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552038
- Sponsor's protocol ID
- AP_GADV_SG_VIH-ODONTO
- Acronym
- VIH-ODONTO
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 25 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Management of Patients Living With HIV: A Retrospective Study Using COREVIH Data in Pays de la Loire
- ClinicalTrials.gov ID
- NCT07552038
- Acronym / sponsor ID
- VIH-ODONTO / AP_GADV_SG_VIH-ODONTO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,603 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 27 Apr 2026 (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.
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.
Detailed description
This is a retrospective descriptive observational study using anonymized data from patients living with HIV followed in the Pays de la Loire region. The dataset includes 5,603 individuals whose data were previously collected as part of routine clinical care and recorded in the Nadis medical database by healthcare professionals involved in HIV management.
Data were provided by the COREVIH Pays de la Loire in an anonymized format and include demographic characteristics (age, sex), HIV-related variables (viral load, duration since diagnosis, antiretroviral therapy status), co-infections (sexually transmitted infections and hepatitis B/C), biological parameters (CD4 lymphocyte count, neutrophil count, platelet count, hemoglobin level), and comorbidities (e.g., diabetes, hypertension, renal disease, cardiovascular conditions, depression).
The primary objective is to determine the proportion of patients presenting biological abnormalities that may increase the risk of infectious or hemorrhagic complications during invasive dental procedures.
Data analysis will consist of descriptive statistics, including frequencies and percentages for categorical variables. The study does not involve any intervention, additional data collection, or direct patient contact.
All data are fully anonymized prior to analysis, ensuring that participants cannot be identified. The study complies with applicable data protection regulations and is based on previously collected clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With HIV | – | Other: HIV infection status and clinical characteristicsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Patients with missing key biological data required for analysis
- Patients not followed in participating centers
- Patients with incomplete medical records preventing assessment of outcomes
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 |
|---|---|---|
| HIV infection status and clinical characteristicsObservational 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. | Other | Patients With HIV |
Primary outcome
Proportion of Patients Requiring Adapted Dental Management
Time frame: At time of data extraction (retrospective baseline)
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.
6 secondary outcomes
CD4 Cell Count Distribution
Time frame: At time of data extraction (retrospective baseline)
Neutrophil Count Distribution
Time frame: At time of data extraction (retrospective baseline)
Platelet Count Distribution
Time frame: At time of data extraction (retrospective baseline)
Hemoglobin Level Distribution
Time frame: At time of data extraction (retrospective baseline)
Prevalence of Comorbidities
Time frame: At time of data extraction (retrospective baseline)
Viral Load Status
Time frame: At time of data extraction (retrospective baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Acquired Immune Deficiency Syndrome, run by Nantes University Hospital 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 25 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilles Amador del Valle, MD, PhD (+33 2 40 08 31 73, gilles.amadordelvalle@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Requiring Adapted Dental Management (time frame: At time of data extraction (retrospective baseline)). 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 25 Jun 2026.