Reducing Antiretroviral Treatments

• Status: Active, not recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Anti-Retroviral Agents; Dolutegravir; Lamivudine

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