Last updated: June 8, 2022
Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Overall Status: Active - Recruiting
Phase
4
Condition
Hiv Infections
Treatment
N/AClinical Study ID
NCT04222283
IMEA 057
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- HIV-1-infected patient
- Age > 65 years old
- Plasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml isallowed in the past 6 months before screening.
- Currently receiving an antiretroviral regimen containing a booster, ritonavir orcobicistat
- No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. Thereverse transcriptase resistant mutations M184V plus one TAM are allowed.
- If no genotype is available, DNA genotype will be performed at screening visit: noresistance mutation to integrase inhibitors, the reverse transcriptase resistantmutations M184V plus one TAM are allowed.
- Patient enrolled in or a beneficiary of a Social Security program (State Medical Aidor AME is not a Social Security program)
- Informed consent form signed by patient and investigator
Exclusion
Exclusion Criteria:
- HIV-2 infection
- Currently receiving one of the following drugs: Hypericum perforatum, rifampicin,rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate,cyclosporine, primidone, ténofovir et adéfovir.
- Hemoglobin < 10g/dL
- Platelets < 100 000/mm3
- Hepatic transaminases AST and ALT > 3x upper limit of normal (ULN)
- Severe hepatic insufficiency (Child Pugh Class C)
- Creatininemia clairance < 30 mL/min (MDRD)
- History or presence of allergy to the trial drugs or their components
- Patients participating in another clinical trial including an exclusion period that isstill ongoing during the screening phase
- Patients under judicial protection due to temporarily and slightly diminished mentalor physical faculties or under legal guardianship.
Study Design
Total Participants: 27
Study Start date:
August 17, 2020
Estimated Completion Date:
June 30, 2022
Study Description
Connect with a study center
Hopital Sainte Marguerite
Marseille, 13009
FranceActive - Recruiting
Hopital Hotel Dieu
Nantes, 44093
FranceActive - Recruiting
Hopital L'Archet
Nice,
FranceActive - Recruiting
Bichat Hospital
Paris, 75018
FranceActive - Recruiting
Hôpital Hotel Dieu
Paris, 75004
FranceActive - Recruiting
CH de Saint Nazaire
Saint-Nazaire,
FranceSite Not Available
Hopital Gustave Dron
Tourcoing, 59208
FranceActive - Recruiting
Hopital Bretonneau
Tours,
FranceSite Not Available
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