NCT06338826View on ClinicalTrials.gov

Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
HIV InfectionsHBV Coinfection
Interventions
DRUG

TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI

"The study will include patients under current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from~* NNRTI = efavirenz, rilpivirine, etravirine, doravirine~* PI/r = atazanavir/r ou darunavir/r~* INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir"

DRUG

Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)

dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR

All Listed Sponsors
lead

ANRS, Emerging Infectious Diseases

OTHER_GOV