Dual Therapy in HIV Patients in 4 Days a Week Versus 7 Days a Week

Last updated: November 5, 2021
Sponsor: ANRS, Emerging Infectious Diseases
Overall Status: Active - Recruiting

Phase

3

Condition

Hiv Infections

Treatment

N/A

Clinical Study ID

NCT04867083
ANRS 177 DUETTO
2020-003951-13
  • Ages 18-99
  • All Genders

Study Summary

The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non inferiority of antiretroviral dual therapy taken 4 consecutive days per week versus antiretroviral dual therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral dual therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • HIV-1 infection, coinfection HIV-1/HIV-2 possible
  • Age≥18 years old
  • Current dual therapy unchanged for the last 6 months with Dolutegravir/ Lamivudine orDolutegravir / Rilpivirine or Darunavir/r / Lamivudine
  • If a genotype is available in the patient medical history; virus must be susceptibleto all on going dual therapy. If no ARN genotype available, the patients can beincluded in the study
  • Viral load (VL) < 50 c/mL in the past twelve months, with at least 3 VL measurementsincluding screening; only one blip < 200 c/mL is authorized in the 6-12 previousmonths
  • CD4 T cells > 250/mm3 at W-4
  • Estimated glomerular filtration rate > 60 mL/min (CKD-EPI method)
  • AST et ALT < 3N
  • Haemoglobin > 10 g/dL
  • Platelets > 100 000/mm3
  • For women of childbearing age, negative pregnancy plasmatic test at W-4 and agree touse efficacy contraception during the study
  • Commitment to use condom prevention and protection during sexual intercourse for theduration of the trial.
  • Social security system coverage (including State Medical Aid-AME, if EC approves it)
  • Informed consent form signed

Exclusion

Exclusion Criteria:

  • Infection by HIV-2
  • Chronic and active Viral B Hepatitis with positive antigen HBs
  • Chronic and active Viral C Hepatitis with treatment expected in the next 48 weeks
  • Concomitant treatment using interferon, interleukins, any other immune-therapy orchemotherapy, antivitamin K+ with co-treatment by booster
  • Concomitant prophylactic or curative treatment for an opportunistic infection
  • All conditions (use of alcohol, drugs, etc.) judged by the investigator to possiblyinterfere with study protocol compliance, observance and/or study treatment tolerance
  • Pregnant or breast feeding women
  • Subjects under "sauvegarde de justice" (judicial protection due to temporarily andslightly diminished mental or physical faculties), or under legal guardianship

Study Design

Total Participants: 440
Study Start date:
June 21, 2021
Estimated Completion Date:
July 31, 2024

Study Description

Open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non-inferiority of antiretroviral dual therapy taken 4 consecutive days a week versus dual therapy taken 7 days a week, in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral dual therapy since 4 months. The non-inferiority margin (delta) is 5%. The randomization will be stratified according to the family of the dual therapy at the moment of the inclusion and according to the participation of the substudy or not.

The sample size calculation assumes that the true difference in efficacy between the two arms is zero and that the overall response rate is 97% at week 48. A total of 440 patients (220 per arm) is required to provide 80% power to demonstrate non-inferior efficacy for the 4/7 strategy, compared to the daily dual therapy (7/7), with a two-sided significance level of 5% and a non-inferiority margin (delta) of -5%.

Connect with a study center

  • Hôpital Louis Pasteur/Service des Maladies Infectieuses

    Chartres, Le Coudray 28630
    France

    Active - Recruiting

  • Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'Immunologie

    Argenteuil Cedex, 95107
    France

    Active - Recruiting

  • Hôpital Avicenne/Service des Maladies Infectieuses et tropicales

    Bobigny cedex, 93009
    France

    Active - Recruiting

  • Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales

    Bordeaux cedex, 33076
    France

    Active - Recruiting

  • Hôpital Saint André/Service HDJ Maladies Infectieuses

    Bordeaux cedex, 33075
    France

    Active - Recruiting

  • Hôpital Côte de Nacre/Service des Maladies Infectieuses

    Caen cedex 9, 14033
    France

    Active - Recruiting

  • Hôpital Antoine Béclère/Service d'Immunologie Clinique et Médecine Interne

    Clamart cedex, 92141
    France

    Active - Recruiting

  • Centre Hospitalier Sud-Francilien/Service d'Hématologie

    Corbeil-Essonnes cedex, 91106
    France

    Active - Recruiting

  • Hôpital François Mitterrand/Service des Maladies Infectieuses

    Dijon cedex, 21079
    France

    Active - Recruiting

  • Hôpital Raymond Poincaré/Service des Maladies Infectieuses

    Garches, 92380
    France

    Active - Recruiting

  • CHD de La Roche sur Yon/Service de Médecine Interne

    La Roche sur Yon cedex 9, 85925
    France

    Active - Recruiting

  • Hôpital Franco-Britannique-Fondation Cognacq-Jay

    Levallois-Perret, 92300
    France

    Active - Recruiting

  • CHU Dupuytren 1/Service des Maladies Infectieuses et Tropicales

    Limoges, 87042
    France

    Active - Recruiting

  • Hôpital de la Croix Rousse/Service des Maladies Infectieuses

    Lyon cedex 4, 69317
    France

    Active - Recruiting

  • Hôpital Européen/Consultation de Médecine Interne et Maladies Infectieuses

    Marseille cedex 01, 13331
    France

    Active - Recruiting

  • Hôpital Sainte Marguerite/Service d'Immuno-Hématologie Clinique

    Marseille cedex 9, 13274
    France

    Active - Recruiting

  • Hôpital Gui de Chauliac/Service des Maladies Infectieuses

    Montpellier cedex 5, 34295
    France

    Active - Recruiting

  • Hôpital de l'Hôtel Dieu/Service des Maladies Infectieuses

    Nantes cedex 1, 44093
    France

    Active - Recruiting

  • Hôpital de l'Archet/Service des Maladies Infectieuses

    Nice cedex 3, 06202
    France

    Active - Recruiting

  • Hôpital Bichat/Service des Maladies Infectieuses

    Paris, 75018
    France

    Active - Recruiting

  • Hôpital Lariboisière/Service de Médecine Interne

    Paris cedex 10, 75475
    France

    Active - Recruiting

  • Hôpital Saint Louis/Service des Maladies Infectieuses

    Paris cedex 10, 75475
    France

    Active - Recruiting

  • Hôpital Saint Antoine/Service des Maladies Infectieuses

    Paris cedex 12, 75571
    France

    Active - Recruiting

  • Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses

    Paris cedex 13, 75651
    France

    Active - Recruiting

  • Hôpital Necker/Service des Maladies Infectieuses

    Paris cedex 15, 75743
    France

    Active - Recruiting

  • Hôpital Tenon/Service des Maladies Infectieuses

    Paris cedex 20, 75970
    France

    Active - Recruiting

  • Hôpital Hôtel Dieu/Service d'Immunologie Clinique

    Paris cedex 4, 75181
    France

    Active - Recruiting

  • Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse

    Paris cedex 4, 75181
    France

    Active - Recruiting

  • Centre hospitalier de Poissy/Service des Maladies Infectieuses

    Poissy, 78300
    France

    Active - Recruiting

  • Centre Hospitalier René Dubos/Service de Dermatologie

    Pontoise, 95301
    France

    Active - Recruiting

  • Hôpital Robert DEBRE/Service des maladies infectieuses

    Reims cedex, 51092
    France

    Site Not Available

  • Hôpital Delafontaine/Service des Maladies Infectieuses

    Saint Denis cedex 1, 93205
    France

    Active - Recruiting

  • Hôpital Civil/Service Le Trait D'union UF 2066

    Strasbourg Cedex, 67091
    France

    Active - Recruiting

  • Hôpital Foch/Service de Médecine Interne

    Suresnes, 92151
    France

    Active - Recruiting

  • Hôpital Purpan/Service des Maladies Infectieuses

    Toulouse cedex, 31059
    France

    Active - Recruiting

  • Hôpital Gustave Dron/Service des Maladies Infectieuses

    Tourcoing cedex, 59208
    France

    Active - Recruiting

  • Hôpital Bretonneau/Service des Maladies Infectieuses

    Tours, 37044
    France

    Active - Recruiting

  • Hôpital Pierre Zobda-Quitman/Service de Médecine Interne

    Fort-de-France, 97261
    Martinique

    Active - Recruiting

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