Status:
COMPLETED
Optimisation of Care in Vulnerable HIV Infected Individuals
Lead Sponsor:
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Collaborating Sponsors:
ViiV Healthcare
Institut de Sante Publique, d'Epidemiologie et de Developpement
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Antiretroviral therapy is currently the only way to control HIV disease progression in HIV infected subjects and to prevent transmission. However a sustained virological control through antiretroviral...
Detailed Description
The OPTICARE program is an individualized program proposed to vulnerable HIV infected patients according to a baseline evaluation of the clinical, social, psychological and cultural aspects. Once enr...
Eligibility Criteria
Inclusion
- Patients Lost to follow-up defined as a patient with no clinical visit:
- In the 12 months period for patients \> 250/mm3 CD4 cells or
- In the 6 months period for patients \< 250/mm3 CD4 cells or
- In the 3 months period following a new HIV + diagnosis or an AIDS defining illnesses
- AND with HIV plasma viral load \> 400 cp/ml (following French HIV guidelines)
- HIV+ patients with virological failure defined as HIV plasma viral load (pVL) \> 400 cp/ml (2 determinations with at least two weeks apart)
- HIV+ patients presenting with an AIDS defining (\<3 months) event in a context of lost to care prior to the event
- HIV+ patients newly diagnosed with virological failure 6 months after ART initiation (virological failure defined by two HIV plasma viral load \> 50cp/ml following French HIV guidelines \*) and with one of the following vulnerable risk factors :
- Social frailty (lack of health insurance, homeless, accommodation by family/friends, post incarceration)
- Migrants with a first arrival in France in the last 6 months
- Women in postpartum period (3 months after delivery)
- Psychiatric disease
- Intravenous drug users, alcohol consumers (women \> 40g/day or \> 2 standard drinks /day; men \> 60g/day ou \> 3 standard drinks/day)
- A standard glass is defined by a quantity of pure alcohol of 10 grams, corresponding to approximately 10 cl of wine, 25 cl of beer at 5% vol, or 3 cl of alcohol at 40% vol. (https://www.sfalcoologie.asso.fr/download/RBP2014-SFA-Mesusage-AA.pdf)
Exclusion
- Patients unwilling to participate.
- Patients with HIV plasma viral load \< 50 cp/ml
- https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03799276
Start Date
January 15 2019
End Date
December 15 2023
Last Update
February 2 2024
Active Locations (1)
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1
Yasmine Dudoit
Paris, France, 75013