ANRS 173 ALTAR (ALlégement du Traitement AntiRétroviral)

ANRS 173 ALTAR A randomized, open-label, phase III trial comparing a dual nucleoside analogues strategy preceded by an induction period with an integrase inhibitor based triple therapy to an immediate two-drug strategy with dolutegravir plus lamivudine in ART naïve people living with HIV with viral load 300/mm3 - ALTAR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001961-34-FR

Enrollment

360

Registered

2019-05-24

Start date

2019-07-10

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv Infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: VIREAD or Tenofovir disoproxil fumarate (generic drug) Pharmaceutical Form: Film-coated tablet Trade Name: STRIBILD 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Documented HIV-1 infection. - Age = 18 years. - Therapeutic antiretroviral treatment-naive participant (history of prophylaxy is accepted) - CD4 count > 300 cells/mm3 at screening visit - HIV-1-RNA plasma viral load 60 mL /min (MDRD) - ASAT, ALAT=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - HIV-2 co-infection - HBV 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 (Appendix A8) - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate at W48 the non-inferiority in terms of efficacy of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) and emtricitabine (FTC) and lamivudine (3TC) preceded by a 16 week induction period with an integrase inhibitor (INI) relative to an immediate 2-DR with dolutegravir plus 3TC, in HIV-1-infected ART naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA lower than 50 000 cp/mL. ;Secondary Objective: To compare over the trial period of 96 weeks the two strategies in terms of: •Rate of virological success at each time point (FDA Snapshot approach) •Rate of virological failure according to the study protocol •Changes in immunological parameters: CD4 cells, CD8 cells, and CD4/CD8 ratio •Changes in blood HIV-DNA •Resistance profile in case of virological failure •Drug concentration at W20 and W48 and in case of virological failure, blip, or premature stop of the trial •Clinical, biological tolerability and safety of each strategy •HIV-RNA levels in blood plasma and semen at D0, W16 and W48 and minimal Drug Concentration (Cmin) of ARV drugs at W16 and W48 in blood plasma and in semen (substudy) •Changes in metabolic parameters •Changes in renal function •Quality of life and disease-related symptoms (self-assessment questionnaire) •Adherence (self-assessment questionnaire) ;Primary end point(s): The primary endpoint of the trial is the proportion of participants with plasma HIV-RNA <50 copies/mLon allocated treatment (FDA snapshot approach). ;Timepoint(s) of evaluation of this end point: at Week 48	—

Measure

Time frame

Main Objective: To demonstrate at W48 the non-inferiority in terms of efficacy of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) and emtricitabine (FTC) and lamivudine (3TC) preceded by a 16 week induction period with an integrase inhibitor (INI) relative to an immediate 2-DR with dolutegravir plus 3TC, in HIV-1-infected ART naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA lower than 50 000 cp/mL. ;Secondary Objective: To compare over the trial period of 96 weeks the two strategies in terms of: •Rate of virological success at each time point (FDA Snapshot approach) •Rate of virological failure according to the study protocol •Changes in immunological parameters: CD4 cells, CD8 cells, and CD4/CD8 ratio •Changes in blood HIV-DNA •Resistance profile in case of virological failure •Drug concentration at W20 and W48 and in case of virological failure, blip, or premature stop of the trial •Clinical, biological tolerability and safety of each strategy •HIV-RNA levels in blood plasma and semen at D0, W16 and W48 and minimal Drug Concentration (Cmin) of ARV drugs at W16 and W48 in blood plasma and in semen (substudy) •Changes in metabolic parameters •Changes in renal function •Quality of life and disease-related symptoms (self-assessment questionnaire) •Adherence (self-assessment questionnaire) ;Primary end point(s): The primary endpoint of the trial is the proportion of participants with plasma HIV-RNA <50 copies/mLon allocated treatment (FDA snapshot approach). ;Timepoint(s) of evaluation of this end point: at Week 48

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints will compare the two strategies at Week 48 and Week 96 in terms of: ? Efficacy • Proportion of participants with virological success (plasma HIV-RNA 95%) with a self-assessment questionnaire at W4, W12, W16, W24, W48, W72 and W96. ;Timepoint(s) of evaluation of this end point: • Evolution of metabolic parameters (fasting triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol and fasting glycemia) from D0 to W48 and W96. • Evolution of renal function evaluated using MDRD formula to estimate the Glomerular Filtration Rate (eGFR) from D0 to W96. • Evolution of health-related quality of life scores from D0 to W16, W24, W48 and W96 (self-assessment questionnaire) • Proportion of participants with adquate adherence rate (>95%) with a self-assessment questionnaire at W4, W12, W16, W24, W48, W72 and W96.	—

Measure

Time frame

Secondary end point(s): The secondary endpoints will compare the two strategies at Week 48 and Week 96 in terms of: ? Efficacy • Proportion of participants with virological success (plasma HIV-RNA 95%) with a self-assessment questionnaire at W4, W12, W16, W24, W48, W72 and W96. ;Timepoint(s) of evaluation of this end point: • Evolution of metabolic parameters (fasting triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol and fasting glycemia) from D0 to W48 and W96. • Evolution of renal function evaluated using MDRD formula to estimate the Glomerular Filtration Rate (eGFR) from D0 to W96. • Evolution of health-related quality of life scores from D0 to W16, W24, W48 and W96 (self-assessment questionnaire) • Proportion of participants with adquate adherence rate (>95%) with a self-assessment questionnaire at W4, W12, W16, W24, W48, W72 and W96.

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Countries

France, Spain

Contacts

Public ContactLucie MARCHAND

INSERM ANRS

lucie.marchand@anrs.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026