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HIV InfectionsPhase 3QUATUORNCT03256422

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

A Phase 3 study testing Treatment discontinuation in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 63 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Treatment discontinuation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
640 participants
Where
63 sitesFrance
Study dates
7 Sep 2017to 2 Mar 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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

Who cannot join

  • 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

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

France63 sites

  • Centre hospitalier Victor Dupouy

    Argenteuil, 95100

  • Hôpital Henri Duffaut

    Avignon, 84000

  • CHRU Jean Minjoz

    Besançon, 25030

  • Avicenne

    Bobigny, 93000

  • Jean Verdier

    Bondy, 93143

  • Hôpital Saint-André

    Bordeaux, 33075

  • Hôpital Pellegrin

    Bordeaux, 33076

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, 92104

  • Hôpital de la Côte de Nacre

    Caen, 14033

  • Hôpital Louis Pasteur

    Chartres, 28630

  • Antoine Beclère

    Clamart, 92140

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Centre hospitalier sud francilien

    Corbeil-Essonnes, 91106

  • CHI de Créteil

    Créteil, 94010

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hôpital du Bocage

    Dijon, 21079

  • Hôpital La Meynard Zobda Quitman

    Fort-de-France, Martinique, 97261

  • Hôpital Raymond Poincaré

    Garches, 92380

  • Hôpital Michallon

    Grenoble, 38043

  • CHD de la Roche Sur Yon

    La Roche-sur-Yon, 85295

  • Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Centre Hospitalier du Mans

    Le Mans, 72037

  • Institut hospitalier franco-britannique

    Levallois-Perret, 92309

  • Hôpital Dupuytren

    Limoges, 87042

  • Hôpital de la Croix Rousse

    Lyon, 69000

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Hôpital Sainte Marguerite

    Marseille, 13274

  • Hôpital Européen

    Marseille, 13331

  • Hôpital Gui de Chauliac

    Montpellier, 34295

  • Hôpital Emile Müller

    Mulhouse

  • Hôpital de l'Hôtel Dieu

    Nantes, 44093

  • Hôpital de l'Archet

    Nice, 06202

  • Hôpital Carémeau

    Nîmes, 30029

  • Hôpital de La Source

    Orléans, 45100

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital Necker

    Paris, 75015

  • Hôpital Bichat

    Paris, 75018

  • Hôpital de l'Hôtel Dieu

    Paris, 75181

  • Hôtel-Dieu

    Paris, 75181

  • Hôpital Saint-Louis

    Paris, 75475

  • Lariboisière

    Paris, 75475

  • Hôpital Pitié-Salpêtrière

    Paris, 75651

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • Tenon

    Paris, 75970

  • Centre Hospitalier de Perpignan

    Perpignan, 66046

  • CHU Pointe-à-Pitre

    Pointe à Pitre, Guadeloupe, 97159

  • Centre Hospitalier René Dubos

    Pontoise, 95301

  • Centre hospitalier Annecy Genevois

    Pringy, 74374

  • Hôpital Robert Debré

    Reims, 51100

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre Hospitalier de Saint-Brieuc

    Saint-Brieuc, 22000

  • Hôpital Delafontaine

    Saint-Denis, 93205

  • Hôpital Nord

    Saint-Etienne, 42055

  • Centre Hospitalier Général de Saint Nazaire

    Saint-Nazaire, 44600

  • Hôpital Civil

    Strasbourg, 67091

  • Hôpital Foch

    Suresnes, 92151

  • Hôpital La Grave

    Toulouse, 31059

  • Hôpital Purpan

    Toulouse, 31059

  • Hôpital Gustave Dron

    Tourcoing, 59208

  • Hôpital Bretonneau

    Tours, 37044

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Hôpital André Mignot

    Versailles, 78157

  • Centre Hospitalier Intercommunal

    Villeneuve-Saint-Georges, 94195

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
HIV Infections
Being tested
Treatment discontinuation
Keywords
Controlled, virological and therapeutic success, treatment discontinution, 4 days per week
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment discontinuationDrug

    • 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
Study groups in NCT03256422
Study groupRoleWhat they receive
4 days / 7ExperimentalPatients included in this arm will take their ARV treatment 4 consecutive days per week during 98 weeks
Receives: Drug: Treatment discontinuation
7 days / 7Active 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
Receives: Drug: Treatment discontinuation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 48

Secondary outcomes (21)

  1. Proportion of patients with therapeutic success at 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.

    Measured: Week 96

  2. Virological success

    The HIV-1 viral load at week 48 must be inferior to 50 copies/mL

    Measured: Week 48 and Week 96

  3. Number of virological " blips "

    viral load > 50 copies/mL followed by a control value ≤ 50 cp/mL

    Measured: between Week 0 and Week 48, and between Week 0 and Week 96

  4. Percentage of patients with a viral load signal detected

    (subgroup of patients tested with Roche-Taqman, threshold<20 copies/mL)

    Measured: between Week 0 and Week 48 and Week 0 and Week 96

  5. Proportion of patients with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by next generation sequencing

    Measured: Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 (if it's necessary)

  6. 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

    Measured: Week 0

  7. 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)

    Immuno-viro-pharmacological sub-study of 120 patients

    Measured: between Week 0, Week 48 and Week 96

  8. Description of the factors associated with virological rebound (viral load >50 cp/mL).

    (viral load >50 cp/mL).

    Measured: Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 (if it's necessary)

  9. 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

    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

    Measured: from Week-4 to Week 48 and Week 96

  10. Evolution of fasting metabolic parameters

    Measurement of total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia

    Measured: until Week 48 and Week 96

  11. Evolution of inflammation and immune activation parameters

    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

    Measured: from Week 0 to Week 24 and Week 48

  12. HIV RNA viral load in semen

    Sperm sub-study (120 patients)

    Measured: Week 0, Week 24 and Week 48

  13. Residual plasmatic concentrations of the third antiretroviral agent

    Measurement of the third antiretroviral agent plasmatic concentration (protease inhibitors or non-nucleoside reverse transcriptase inhibitors or integrase inhibitors)

    Measured: Week 0, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96

  14. Residual plasmatic concentrations of tenofovir (TDF or TAF)

    Measurement of tenofovir plasmatic concentration

    Measured: Week 0, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96

  15. Residual intracellular concentrations of the third antiretroviral agents

    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)

    Measured: Week 0, Week 24 and Week 48

  16. Treatment adherence

    Evaluation by a self-reported questionnaire

    Measured: Week 0, Week 12, Week 24, Week 36, Week 48, Week 72,and Week 96

  17. Patient Quality of life

    Evaluation by a self-reported questionnaire

    Measured: Week-4, Week 0, Week 48 and Week 96

  18. Patient satisfaction

    Evaluation by a self-reported questionnaire

    Measured: Week 0, Week 12, Week 48 and Week 96

  19. Pharmaco-economic aspects of the strategy

    Assessment and comparison of cost essay between each arm.

    Measured: Between Week 0 and Week 98

  20. Median time to virologic failure

    Measure the delay between week 0 and the date of different virologic failure

    Measured: Between week 0 and 98

  21. Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE)

    according to the sponsor's grading scale

    Measured: Between Week 0 and Week 98

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start7 Sep 2017
  3. Primary completion6 Aug 2019
  4. Study completion2 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, randomized trial in 2 parallel groups
Masking
None (open label)
Enrolment
640 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03256422
Sponsor's protocol ID
ANRS 170 - QUATUOR
Other IDs
2017-000040-17, 2017
Acronym
QUATUOR
Status last verified
Aug 2017
First submitted
9 Aug 2017
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35120640

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Treatment discontinuation in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 63 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with therapeutic success at Week 48. (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03256422, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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