- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051970
Reducing Antiretroviral Treatments (ALTAR)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Paris, France
- Hopital La Salpétrière
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Strategy TRI-BI
|
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. |
ACTIVE_COMPARATOR: Strategy Immediate BI
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
proportion of participants with plasma HIV-RNA <50 copies/mL at Week 48 in the 2 arms on allocated treatment (FDA snapshot approach)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANRS 173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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