Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
QUATUOR
Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Treatment Taken 4 Consecutive Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Therapy
2 other identifiers
interventional
640
1 country
63
Brief Summary
The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a week versus continuous therapy, in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral treatment since 4 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Sep 2017
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedStudy Start
First participant enrolled
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2020
CompletedApril 13, 2026
August 1, 2017
1.9 years
August 9, 2017
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with therapeutic success at Week 48.
To evaluate after 48 weeks the therapeutic success of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, defined by : * absence of virological failure : a measure of the viral load will be done, this measure have to be \< 50 cp/mL. If it's \> 50 cp/mL, a second measure will be done at 2 to 4 weeks apart. If it's still \> 50 cp/mL, it's a virological failure * no discontinuation or modification of the study strategy for more than 30 consecutive days.
Week 48
Secondary Outcomes (21)
Proportion of patients with therapeutic success at Week 96
Week 96
Virological success
Week 48 and Week 96
Number of virological " blips "
between Week 0 and Week 48, and between Week 0 and Week 96
Percentage of patients with a viral load signal detected
between Week 0 and Week 48 and Week 0 and Week 96
Proportion of patients with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by next generation sequencing
Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 (if it's necessary)
- +16 more secondary outcomes
Study Arms (2)
4 days / 7
EXPERIMENTALPatients included in this arm will take their ARV treatment 4 consecutive days per week during 98 weeks
7 days / 7
ACTIVE COMPARATORPatients included in this arm will continue their ARV therapy 7 days per weeks during 48 weeks and after W48, they will take their ARV treatment 4 days per week until W98
Interventions
• Receiving tritherapy. Allowed treatment drugs are : 1. nucleoside analogs : tenofovir (TDF ou TAF), emtricitabine, abacavir, lamivudine 2. protease inhibitors : lopinavir/r, darunavir/r ou atazanavir/r 3. non nucleoside reverse transcriptase inhibitors : efavirenz, rilpivirine ou etravirine 4. integrase inhibitors : dolutegravir, elvitegravir/cobicistat ou raltegravir
Eligibility Criteria
You may qualify if:
- HIV-1 infection, coinfection HIV-1/HIV-2 possible
- Age≥18 years old
- Current therapy unchanged for the last 4 months
- Receiving tritherapy with 2 nucleoside reverse transcriptase inhibitor+protease inhibitors or 2 nucleoside reverse transcriptase inhibitor+non-nucleoside reverse transcriptase inhibitors or 2 nucleoside reverse transcriptase inhibitor+integrase inhibitors.
- Allowed treatment drugs are :
- \. nucleoside analogs : tenofovir (TDF ou TAF), emtricitabine, abacavir, lamivudine 2. protease inhibitors : lopinavir/r, darunavir/r ou atazanavir/r 3. Non nucleoside reverse transcriptase inhibitors : efavirenz, rilpivirine ou etravirine 4. integrase inhibitors : dolutegravir, elvitegravir/cobicistat ou raltegravir
- Viruses susceptible to all antiretroviral drugs present in the ongoing tritherapy (AC11-ANRS algorithm).
- If a genotype is available in the patient medical history; viruses must be susceptible to all ongoing antiretroviral drugs
- If no RNA genotype available, a genotype will be performed on DNA at screening and will not have to show any resistance to the ongoing antiretroviral drugs
- Viral load (VL) \< 50 cp/mL in the past year, with at least 3 VL measurements including screening; only one episode of viral blip \< 200 copies/mL is authorized in the last year
- CD4 T cells \> 250/mm3 at the screening visit
- Estimated glomerular filtration rate \> 60 mL/min (Chronic Kidney Disease - Epidemiology Collaboration method)
- Transaminases : aspartate aminotransférase et alanine aminotransférase \< 3N
- Haemoglobin \> 10 g/dL
- Platelets \> 100 000/mm3
- +3 more criteria
You may not qualify if:
- 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 98 weeks
- Concomitant treatment using interferon, interleukins, any other immune-therapy or chemotherapy, antivitaminK for patients on ARVT using a booster
- Concomitant prophylactic or curative treatment for an opportunistic infection
- All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere 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 and slightly diminished mental or physical faculties), or under legal guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
CHU Pointe-à-Pitre
Pointe à Pitre, Guadeloupe, 97159, France
Hôpital La Meynard Zobda Quitman
Fort-de-France, Martinique, 97261, France
Centre hospitalier Victor Dupouy
Argenteuil, 95100, France
Hôpital Henri Duffaut
Avignon, 84000, France
CHRU Jean Minjoz
Besançon, 25030, France
Avicenne
Bobigny, 93000, France
Jean Verdier
Bondy, 93143, France
Hôpital Saint-André
Bordeaux, 33075, France
Hôpital Pellegrin
Bordeaux, 33076, France
Hôpital Ambroise Paré
Boulogne-Billancourt, 92104, France
Hôpital de la Côte de Nacre
Caen, 14033, France
Hôpital Louis Pasteur
Chartres, 28630, France
Antoine Beclère
Clamart, 92140, France
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003, France
Centre hospitalier sud francilien
Corbeil-Essonnes, 91106, France
CHI de Créteil
Créteil, 94010, France
Hôpital Henri Mondor
Créteil, 94010, France
Hôpital du Bocage
Dijon, 21079, France
Hôpital Raymond Poincaré
Garches, 92380, France
Hôpital Michallon
Grenoble, 38043, France
CHD de la Roche Sur Yon
La Roche-sur-Yon, 85295, France
Bicêtre
Le Kremlin-Bicêtre, 94275, France
Centre Hospitalier du Mans
Le Mans, 72037, France
Institut hospitalier franco-britannique
Levallois-Perret, 92309, France
Hôpital Dupuytren
Limoges, 87042, France
Hôpital de la Croix Rousse
Lyon, 69000, France
Hôpital Edouard Herriot
Lyon, 69437, France
Hôpital Sainte Marguerite
Marseille, 13274, France
Hôpital Européen
Marseille, 13331, France
Hôpital Gui de Chauliac
Montpellier, 34295, France
Hôpital Emile Müller
Mulhouse, France
Hôpital de l'Hôtel Dieu
Nantes, 44093, France
Hôpital de l'Archet
Nice, 06202, France
Hôpital Carémeau
Nîmes, 30029, France
Hôpital de La Source
Orléans, 45100, France
Hôpital Saint-Antoine
Paris, 75012, France
Hôpital Necker
Paris, 75015, France
Hôpital Bichat
Paris, 75018, France
Hôpital de l'Hôtel Dieu
Paris, 75181, France
Hôtel-Dieu
Paris, 75181, France
Hôpital Saint-Louis
Paris, 75475, France
Lariboisière
Paris, 75475, France
Hôpital Pitié-Salpêtrière
Paris, 75651, France
Hôpital Européen Georges Pompidou
Paris, 75908, France
Tenon
Paris, 75970, France
Centre Hospitalier de Perpignan
Perpignan, 66046, France
Centre Hospitalier René Dubos
Pontoise, 95301, France
Centre hospitalier Annecy Genevois
Pringy, 74374, France
Hôpital Robert Debré
Reims, 51100, France
Hôpital Pontchaillou
Rennes, 35033, France
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, 22000, France
Hôpital Delafontaine
Saint-Denis, 93205, France
Hôpital Nord
Saint-Etienne, 42055, France
Centre Hospitalier Général de Saint Nazaire
Saint-Nazaire, 44600, France
Hôpital Civil
Strasbourg, 67091, France
Hôpital Foch
Suresnes, 92151, France
Hôpital La Grave
Toulouse, 31059, France
Hôpital Purpan
Toulouse, 31059, France
Hôpital Gustave Dron
Tourcoing, 59208, France
Hôpital Bretonneau
Tours, 37044, France
Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511, France
Hôpital André Mignot
Versailles, 78157, France
Centre Hospitalier Intercommunal
Villeneuve-Saint-Georges, 94195, France
Related Publications (1)
Landman R, de Truchis P, Assoumou L, Lambert S, Bellet J, Amat K, Lefebvre B, Allavena C, Katlama C, Yazdanpanah Y, Molina JM, Petrov-Sanchez V, Gibowski S, Alvarez JC, Leibowitch J, Capeau J, Fellahi S, Duracinsky M, Morand-Joubert L, Costagliola D, Alvarez JC, Girard PM; ANRS 170 QUATUOR study group. A 4-days-on and 3-days-off maintenance treatment strategy for adults with HIV-1 (ANRS 170 QUATUOR): a randomised, open-label, multicentre, parallel, non-inferiority trial. Lancet HIV. 2022 Feb;9(2):e79-e90. doi: 10.1016/S2352-3018(21)00300-3.
PMID: 35120640RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre De Truchis, MD
Hôpital Raymond Poincaré
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
August 9, 2017
First Posted
August 22, 2017
Study Start
September 7, 2017
Primary Completion
August 6, 2019
Study Completion
March 2, 2020
Last Updated
April 13, 2026
Record last verified: 2017-08