Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients (QUATUOR)

April 9, 2026 updated by: ANRS, Emerging Infectious Diseases

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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. The non-inferiority margin (delta) is 5%. The randomization will be stratified according to the family of the third antiretroviral agent (II, PI, and NNRTI). A minimum of 200 patients will be included in the integrase inhibitor strata to provide a sufficient power to assess the efficacy of strategy in this population.

At W48, all patients with virological success in the continuous therapy group will switch to the 4/7 days therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
640

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
        • Centre Hospitalier Victor Dupouy
      • Avignon, France, 84000
        • Hôpital Henri Duffaut
      • Besançon, France, 25030
        • CHRU Jean Minjoz
      • Bobigny, France, 93000
        • Avicenne
      • Bondy, France, 93143
        • Jean Verdier
      • Bordeaux, France, 33076
        • Hôpital Pellegrin
      • Bordeaux, France, 33075
        • Hôpital Saint-André
      • Boulogne-Billancourt, France, 92104
        • Hôpital Ambroise Paré
      • Caen, France, 14033
        • Hôpital de la Côte de Nacre
      • Chartres, France, 28630
        • Hopital Louis Pasteur
      • Clamart, France, 92140
        • Antoine Beclère
      • Clermont-Ferrand, France, 63003
        • Hopital Gabriel Montpied
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud Francilien
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • Créteil, France, 94010
        • CHI de Créteil
      • Dijon, France, 21079
        • Hôpital du Bocage
      • Garches, France, 92380
        • Hopital Raymond Poincare
      • Grenoble, France, 38043
        • Hôpital Michallon
      • La Roche-sur-Yon, France, 85295
        • CHD de la Roche Sur Yon
      • Le Kremlin-Bicêtre, France, 94275
        • BICETRE
      • Le Mans, France, 72037
        • Centre Hospitalier du Mans
      • Levallois-Perret, France, 92309
        • Institut hospitalier franco-britannique
      • Limoges, France, 87042
        • Hôpital Dupuytren
      • Lyon, France, 69437
        • Hopital Edouard Herriot
      • Lyon, France, 69000
        • Hôpital de La Croix Rousse
      • Marseille, France, 13274
        • Hôpital Sainte Marguerite
      • Marseille, France, 13331
        • Hopital Europeen
      • Montpellier, France, 34295
        • Hopital Gui de Chauliac
      • Mulhouse, France
        • Hôpital Emile Muller
      • Nantes, France, 44093
        • Hôpital de l'Hôtel Dieu
      • Nice, France, 06202
        • Hôpital de l'Archet
      • Nîmes, France, 30029
        • Hopital Caremeau
      • Orléans, France, 45100
        • Hôpital de la Source
      • Paris, France, 75012
        • Hôpital Saint-Antoine
      • Paris, France, 75908
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75015
        • Hopital Necker
      • Paris, France, 75018
        • Hôpital Bichat
      • Paris, France, 75475
        • Hopital Saint-Louis
      • Paris, France, 75651
        • Hopital Pitie-Salpetriere
      • Paris, France, 75181
        • Hôpital de l'Hôtel Dieu
      • Paris, France, 75181
        • Hôtel-Dieu
      • Paris, France, 75475
        • Lariboisière
      • Paris, France, 75970
        • Tenon
      • Perpignan, France, 66046
        • Centre Hospitalier de Perpignan
      • Pontoise, France, 95301
        • Centre Hospitalier René Dubos
      • Pringy, France, 74374
        • Centre Hospitalier Annecy Genevois
      • Reims, France, 51100
        • Hôpital Robert Debré
      • Rennes, France, 35033
        • Hôpital Pontchaillou
      • Saint-Brieuc, France, 22000
        • Centre Hospitalier de Saint-Brieuc
      • Saint-Denis, France, 93205
        • Hopital DELAFONTAINE
      • Saint-Etienne, France, 42055
        • Hopital Nord
      • Saint-Nazaire, France, 44600
        • Centre Hospitalier Général de Saint Nazaire
      • Strasbourg, France, 67091
        • Hôpital Civil
      • Suresnes, France, 92151
        • Hopital Foch
      • Toulouse, France, 31059
        • Hopital Purpan
      • Toulouse, France, 31059
        • Hôpital La Grave
      • Tourcoing, France, 59208
        • Hôpital Gustave Dron
      • Tours, France, 37044
        • Hopital Bretonneau
      • Vandœuvre-lès-Nancy, France, 54511
        • Hôpital de Brabois
      • Versailles, France, 78157
        • Hopital Andre Mignot
      • Villeneuve-Saint-Georges, France, 94195
        • Centre Hospitalier Intercommunal
    • Guadeloupe
      • Pointe à Pitre, Guadeloupe, France, 97159
        • CHU Pointe-à-Pitre
    • Martinique
      • Fort-de-France, Martinique, France, 97261
        • Hôpital La Meynard Zobda Quitman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 :

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

  • Viruses susceptible to all antiretroviral drugs present in the ongoing tritherapy (AC11-ANRS algorithm).

    1. If a genotype is available in the patient medical history; viruses must be susceptible to all ongoing antiretroviral drugs
    2. 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
  • For women of childbearing age, negative pregnancy test at screening; agree to use mechanical contraception during the study
  • Social security system coverage
  • Informed consent form signed by patient and investigator

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 4 days / 7
Patients included in this arm will take their ARV treatment 4 consecutive days per week during 98 weeks
Drug: Treatment discontinuation

• 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
Active Comparator: 7 days / 7
Patients 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
Drug: Treatment discontinuation

• 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with therapeutic success at Week 48.
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with therapeutic success at Week 96
Time Frame: Week 96

To evaluate after 96 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 96
Virological success
Time Frame: Week 48 and Week 96
The HIV-1 viral load at week 48 must be inferior to 50 copies/mL
Week 48 and Week 96
Number of virological " blips "
Time Frame: between Week 0 and Week 48, and between Week 0 and Week 96
viral load > 50 copies/mL followed by a control value ≤ 50 cp/mL
between Week 0 and Week 48, and between Week 0 and Week 96
Percentage of patients with a viral load signal detected
Time Frame: between Week 0 and Week 48 and Week 0 and Week 96
(subgroup of patients tested with Roche-Taqman, threshold<20 copies/mL)
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
Time Frame: Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 (if it's necessary)
Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 (if it's necessary)
Frequency of minority resistant variants archived in DNA at Week 0 and their impact on virological failure (2 consecutive VL> 50 copies / mL) and on the acquisition of drugs resistance mutations
Time Frame: Week 0
Week 0
Evolution of ultra sensitive viral load and total DNA in the peripheral blood mononuclear cells at Week 0, Week 24, Week 48 and Week 96; evolution of viral genotypic sequence between Week 0, Week 48 and Week 96 (subgroup of 120 patients)
Time Frame: between Week 0, Week 48 and Week 96
Immuno-viro-pharmacological sub-study of 120 patients
between Week 0, Week 48 and Week 96
Description of the factors associated with virological rebound (viral load >50 cp/mL).
Time Frame: Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 (if it's necessary)
(viral load >50 cp/mL).
Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 (if it's necessary)
Evolution of T cluster of differentiation 4 and cluster of differentiation 8 cells count, and T cluster of differentiation 4 /cluster of differentiation 8 ratio
Time Frame: from Week-4 to Week 48 and Week 96
Measurement of T cluster of differentiation 4 cell count, T cluster of differentiation 8 cell count, and T cluster of differentiation 4 /T cluster of differentiation 8 ratio
from Week-4 to Week 48 and Week 96
Evolution of fasting metabolic parameters
Time Frame: until Week 48 and Week 96
Measurement of total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia
until Week 48 and Week 96
Evolution of inflammation and immune activation parameters
Time Frame: from Week 0 to Week 24 and Week 48
Measurement of sCD14, sCD163, IP-10, C-reactive protein, interleukin-6 et D-dimerus, soluble TNF receptor 1, soluble TNF receptor 2 Immuno-viro-Pharmacological Sub-study in 120 patients
from Week 0 to Week 24 and Week 48
HIV RNA viral load in semen
Time Frame: Week 0, Week 24 and Week 48
Sperm sub-study (120 patients)
Week 0, Week 24 and Week 48
Residual plasmatic concentrations of the third antiretroviral agent
Time Frame: Week 0, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96
Measurement of the third antiretroviral agent plasmatic concentration (protease inhibitors or non-nucleoside reverse transcriptase inhibitors or integrase inhibitors)
Week 0, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96
Residual plasmatic concentrations of tenofovir (TDF or TAF)
Time Frame: Week 0, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96
Measurement of tenofovir plasmatic concentration
Week 0, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96
Residual intracellular concentrations of the third antiretroviral agents
Time Frame: Week 0, Week 24 and Week 48
Immuno-viro-Pharmacological sub-study (120 patients) Measurement of the third antiretroviral agent intracellular concentration (protease inhibitors or non-nucleoside reverse transcriptase inhibitors or integrase inhibitors)
Week 0, Week 24 and Week 48
Treatment adherence
Time Frame: Week 0, Week 12, Week 24, Week 36, Week 48, Week 72,and Week 96
Evaluation by a self-reported questionnaire
Week 0, Week 12, Week 24, Week 36, Week 48, Week 72,and Week 96
Patient satisfaction
Time Frame: Week 0, Week 12, Week 48 and Week 96
Evaluation by a self-reported questionnaire
Week 0, Week 12, Week 48 and Week 96
Pharmaco-economic aspects of the strategy
Time Frame: Between Week 0 and Week 98
Assessment and comparison of cost essay between each arm.
Between Week 0 and Week 98
Median time to virologic failure
Time Frame: Between week 0 and 98
Measure the delay between week 0 and the date of different virologic failure
Between week 0 and 98
Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE)
Time Frame: Between Week 0 and Week 98
according to the sponsor's grading scale
Between Week 0 and Week 98
Patient Quality of life
Time Frame: Week-4, Week 0, Week 48 and Week 96
Evaluation by a self-reported questionnaire
Week-4, Week 0, Week 48 and Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ANRS, Emerging Infectious Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre De Truchis, MD, Hopital Raymond Poincare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANRS 170 - QUATUOR
  • 2017-000040-17 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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