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Sponsor: ANRS, Emerging Infectious Diseases
Conditions: HIV-1-infection
Interventions: Antiretroviral
Countries: France
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
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Documented HIV-1 infection (positive HIV-1 serology or plasma viral load) * Age ≥ 18 years * Therapeutic antiretroviral treatment-naive participant (history of prophylaxy is accepted) * CD4 cells count \> 300 cells/mm3 at screening visit * HIV-1-RNA plasma viral load \<50 000 copies/mL at screening visit * Full susceptibility to trial drugs (NRTI, INI) at screening visit * eGFR (epidermal growth factor receptor) \> 60 mL /min (MDRD) * AST (aspartate aminotransferase), ALT(alanine transaminase) \< 3x norm * Absence of any AIDS-defining event and/or opportunistic infection * Possible contact by phone and/or email in order to be informed in case of detectable HIV plasma viral load * Negative urinary pregnancy test at screening visit for women of childbearing age * Written and informed consent signed * For French participants only: subject enrolled in or a beneficiary of a Social Security programme (including State Medical Aid (AME), only if Ethic Committee approves it) Exclusion Criteria: * HIV-2 co-infection * Hepatitis B Virus infection (positive HBs antigen) * Any comorbidity potentially related to a life expectancy below 12 months * Any condition (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance * Pregnant women or breastfeeding women * Women of childbearing age that do not want to use an effective method of contraception * Participant under justice protection * Galactose/lactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (known or documented) * Participation to another clinical trial evaluating a new treatment/therapy
- Paris, France