ALTAR: Reducing Antiretroviral Treatments
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Strategy TRI-BI
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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.
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Active Comparator: Strategy Immediate BI
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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.
|
Outcome Measures
Primary Outcome Measures
- To demonstrate at W48 the non-inferiority [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented HIV-1 infection (positive HIV-1 serology or plasma viral load)
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Age ≥ 18 years
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Therapeutic antiretroviral treatment-naive participant (history of prophylaxy is accepted)
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CD4 cells count > 300 cells/mm3 at screening visit
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HIV-1-RNA plasma viral load <50 000 copies/mL at screening visit
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Full susceptibility to trial drugs (NRTI, INI) at screening visit
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eGFR (epidermal growth factor receptor) > 60 mL /min (MDRD)
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AST (aspartate aminotransferase), ALT(alanine transaminase) < 3x norm
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Absence of any AIDS-defining event and/or opportunistic infection
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Possible contact by phone and/or email in order to be informed in case of detectable HIV plasma viral load
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Negative urinary pregnancy test at screening visit for women of childbearing age
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Written and informed consent signed
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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:
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HIV-2 co-infection
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Hepatitis B Virus infection (positive HBs antigen)
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Any comorbidity potentially related to a life expectancy below 12 months
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Any condition (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
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Pregnant women or breastfeeding women
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Women of childbearing age that do not want to use an effective method of contraception
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Participant under justice protection
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Galactose/lactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (known or documented)
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Participation to another clinical trial evaluating a new treatment/therapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hôpital la Salpêtrière | Paris | France |
Sponsors and Collaborators
- ANRS, Emerging Infectious Diseases
- Institut National de la Santé Et de la Recherche Médicale, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANRS 173