Reducing Antiretroviral Treatments

NCT04051970 | Unknown Phase 3 DMC

• 1 other identifier: ANRS 173
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• To demonstrate at W48 the non-inferiority

  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)

Study Arms (2)

Strategy TRI-BI

EXPERIMENTAL

Drug: Antiretroviral

Strategy Immediate BI

ACTIVE COMPARATOR

Drug: Antiretroviral

Interventions

Antiretroviral DRUG

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.

Strategy Immediate BI; Strategy TRI-BI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hôpital la Salpêtrière

Paris, France

Location

MeSH Terms

Interventions

Anti-Retroviral Agents

Intervention Hierarchy (Ancestors)

Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 9, 2019
• Study Start: November 27, 2019
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)