Low recruitment rate

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

ANRS 173 ALTAR is a multicenter, comparative, international, open label, phase III randomized trial aiming at evaluating the non-inferiority of a TRI-BI (tritherapy-bitherapy) strategy (includes a 16 week - induction phase with 2 NRTI and a once daily integrase inhibitor followed by a bitherapy with TDF or TAF / XTC*) in its capacity to achieve viral suppression at week 48 versus immediate BI (bitherapy) strategy (DTG/3TC) in participants naïve to antiretroviral therapy with plasma HIV RNA strictly less than 50 000 copies/mL and CD4 cells count above 300/mm3.

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