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Reducing Antiretroviral Treatments
Sponsor: ANRS, Emerging Infectious Diseases
Summary
The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudine (3TC) preceded by a 16 week induction period with TDF or TAF plus FTC or 3TC plus an integrase inhibitor (INI) relative to an immediate 2-DR strategy with dolutegravir plus 3TC in HIV-infected antiretroviral therapy (ARV) naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA strictly lower than 50 000 cp/mL
Official title: Randomized, Open-label, Phase III Trial Comparing a Dual Nucleoside Analogues Strategy Preceded by a Triple Therapy Induction Period to an Immediate Strategy With Dolutegravir Plus Lamivudine in Antiretriviral naïve People Living With HIV With Viral Load < 50000 cp/mL and CD4 Cells >300/mm3
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2019-11-27
Completion Date
2022-12-14
Last Updated
2026-06-08
Healthy Volunteers
No
Conditions
Interventions
Antiretroviral
Antiretroviral treatments (ART) will be allocated through central randomization (1:1:) according to the following two strategies: Tritherapy-Bitherapy (TRI-BI) strategy: TRI between D0 and W16: 3-drug combination (3-DR) including 2 NRTI (either TDF or TAF+XTC) and a once daily integrase inhibitor (Stribild® or Genvoya® or Biktarvy®) or TDF/XTC Gé + Tivicay® or TDF/XTC Gé + Isentress® QD 1200 mg when available) during 16 weeks BI between W16 and W96: if pVL viral load \<500 cp/mL at W4 and \<50 cp/mL at W12, participants will start the 2-DR regimen TDF or TAF / XTC (TDF/XTC Gé or Descovy®) at W16, until W96. (Descovy® : provided that it is available in France), (XTC = FTC or 3TC) Immediate Bitherapy (BI) strategy Dolutegravir (DTG, Tivicay® 50 mg QD) plus lamivudine (3TC, 300 mg QD) between D0 and W96. Antiretroviral drugs will be prescribed in the context of standard of care.
Locations (1)
Hôpital la Salpêtrière
Paris, France