Patients Affected by the HIVOVIHDNCT02203006
HIV Patients Cohort
A study testing OVIHD in people with Patients Affected by the HIV, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to improve our knowledge concerning HIV infection, treated or not, in the current conditions of care to optimize it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Affected by the HIV
- What is being tested?
- OVIHD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,613 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2011to 19 Nov 2030
- Phase
- Interventional
- 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
Who may be able to join
- Aged ≥18 years old,
- Patients with an HIV infection
- patients having given their written informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Constitution of an Open Monocentric Cohort of HIV Infected Patients
The purpose of this study is to improve our knowledge concerning HIV infection, treated or not, in the current conditions of care to optimize it.
Read the detailed description
Since the arrival of highly active tritherapies, HIV infection became mainly an ambulatory chronic pathology centred on a long term care taking into account the complication of long-term treatment as well as the arisen of new problem bound to a prolonged survival and ageing. So the care is more and more in a prevention and screening approach with in particular the care of metabolic and cardiovascular complication due to antiretroviral treatment.
As a reorganization of the coverage of the HIV infected people take place on the Hotel Dieu Hospital it thus seems important to double this care optimization with a clinical research side. This will be done in constituting an HIV patient cohort including a blood sample collection to contribute to the vigilance of the complication to due the infection.
Our ultimate objective is to optimize the selection of the treatment. It is important to do it to be able to have, on many years duration, precise clinical information and biological sample allowing to realize later some assay and analyse the influence of some genetic markers.
- Conditions
- Patients Affected by the HIV
- Being tested
- OVIHD
- Keywords
- HIV,, infection,, cohort
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVIHDBiological
Also called Blood sample
7 ml of blood will be taken during a follow-up consultation and kept in a biological collection. Clinical data will be collected in a database.
| Study group | Role | What they receive |
|---|---|---|
| OVIHD | Other | Cohort and a blood sample collection will be done with data and blood of HIV infected patients Receives: Biological: OVIHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV infection
The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
Measured: 10 years
Secondary outcomes (3)
Comorbidity and complication in HIV infected patients
The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
Measured: 10 years
efficiency of the current antiretroviral therapeutic diets
The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
Measured: 10 years
Blood sample collection
To put in relation the clinical-biological relevant biological or genetic data of the follow-up a blood sample will be constituted. 7 ml will be taken to each patient and kept in a collection
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 posted29 Jul 2014 (estimated)
- Study start19 Oct 2011
- Primary completion19 Nov 2030 (estimated)
- Study completion19 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Affected by the HIVStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Tréluyer, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203006
- Sponsor's protocol ID
- IDRCB : 2010-A00417-32
- Acronym
- OVIHD
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2014
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution of an Open Monocentric Cohort of HIV Infected Patients
- ClinicalTrials.gov ID
- NCT02203006
- Acronym / sponsor ID
- OVIHD / IDRCB : 2010-A00417-32
- Conditions
- Patients Affected by the HIV
- Keywords
- HIV,, infection,, cohort
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,613 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Oct 2011 (actual)
- Primary completion
- 19 Nov 2030 (estimated)
- Study completion
- 19 Nov 2030 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- 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.
The purpose of this study is to improve our knowledge concerning HIV infection, treated or not, in the current conditions of care to optimize it.
Detailed description
Since the arrival of highly active tritherapies, HIV infection became mainly an ambulatory chronic pathology centred on a long term care taking into account the complication of long-term treatment as well as the arisen of new problem bound to a prolonged survival and ageing. So the care is more and more in a prevention and screening approach with in particular the care of metabolic and cardiovascular complication due to antiretroviral treatment.
As a reorganization of the coverage of the HIV infected people take place on the Hotel Dieu Hospital it thus seems important to double this care optimization with a clinical research side. This will be done in constituting an HIV patient cohort including a blood sample collection to contribute to the vigilance of the complication to due the infection.
Our ultimate objective is to optimize the selection of the treatment. It is important to do it to be able to have, on many years duration, precise clinical information and biological sample allowing to realize later some assay and analyse the influence of some genetic markers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OVIHD | Other | Biological: OVIHDCohort and a blood sample collection will be done with data and blood of HIV infected patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years old,
- Patients with an HIV infection
- patients having given their written informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OVIHDAlso: Blood sample7 ml of blood will be taken during a follow-up consultation and kept in a biological collection. Clinical data will be collected in a database. | Biological | OVIHD |
Primary outcome
HIV infection
Time frame: 10 years
The HIV cohort will be constituted in collecting cardiovascular, neurological clinical data and medical past history (in case of women patient)
3 secondary outcomes
Comorbidity and complication in HIV infected patients
Time frame: 10 years
efficiency of the current antiretroviral therapeutic diets
Time frame: 10 years
Blood sample collection
Time frame: 10 years
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 6 May 2026.
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.
Jean-Marc Tréluyer, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OVIHD in people with Patients Affected by the HIV, run by Assistance Publique - Hôpitaux de Paris 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 0 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: under way, not looking for participants, as of the sponsor's last update on 6 May 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?
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?
HIV infection (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 6 May 2026.