Reducing Antiretroviral Treatments

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2023

Detailed Description

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.

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: Strategy TRI-BI
  • Active Comparator: Strategy Immediate BI

Clinical Trial Outcome Measures

Primary Measures

  • To demonstrate at W48 the non-inferiority
    • Time Frame: proportion of participants with plasma HIV-RNA <50 copies/mL at Week 48 in the 2 arms on allocated treatment (FDA snapshot approach)
    • 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 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 ART 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ANRS, Emerging Infectious Diseases
  • Collaborator
    • Institut National de la Santé Et de la Recherche Médicale, France
  • Provider of Information About this Clinical Study
    • Sponsor

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