Clinical trial NCT04051970: Reducing Antiretroviral Treatments
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV-1-infection
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-08-09
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: To demonstrate at W48 the non-inferiority
timeFrame: proportion of participants with plasma HIV-RNA <50 copies/mL at Week 48 in the 2 arms on allocated treatment (FDA snapshot approach)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital la Salpêtrière
Study officials:
References: