Reducing Antiretroviral Treatments (ALTAR)

ANRS, Emerging Infectious Diseases

Status and phase

Unknown

Phase 3

Conditions

HIV-1-infection

Treatments

Drug: Antiretroviral

Study type

Interventional

Funder types

Other

Identifiers

NCT04051970

ANRS 173

Details and patient eligibility

About

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 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.

Enrollment

360 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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