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

NCT ID: NCT03256422

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, randomized trial in 2 parallel groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4 days / 7

Patients included in this arm will take their ARV treatment 4 consecutive days per week during 98 weeks

Group Type EXPERIMENTAL

Treatment discontinuation

Intervention Type DRUG

• 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

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

Group Type ACTIVE_COMPARATOR

Treatment discontinuation

Intervention Type DRUG

• 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IMEA Leon M'Ba Foundation

UNKNOWN

Sponsor Role collaborator

INSERM UMR S 1136

OTHER

Sponsor Role collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre De Truchis, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Raymond Poincaré

Locations

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CHU Pointe-à-Pitre

Pointe à Pitre, Guadeloupe, France

Site Status

Hôpital La Meynard Zobda Quitman

Fort-de-France, Martinique, France

Site Status

Centre hospitalier Victor Dupouy

Argenteuil, , France

Site Status

Hôpital Henri Duffaut

Avignon, , France

Site Status

CHRU Jean Minjoz

Besançon, , France

Site Status

Avicenne

Bobigny, , France

Site Status

Jean Verdier

Bondy, , France

Site Status

Hôpital Saint-André

Bordeaux, , France

Site Status

Hôpital Pellegrin

Bordeaux, , France

Site Status

Hôpital Ambroise Paré

Boulogne-Billancourt, , France

Site Status

Hôpital de la Côte de Nacre

Caen, , France

Site Status

Hôpital Louis Pasteur

Chartres, , France

Site Status

Antoine Beclère

Clamart, , France

Site Status

Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Centre hospitalier sud francilien

Corbeil-Essonnes, , France

Site Status

CHI de Créteil

Créteil, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

Hôpital du Bocage

Dijon, , France

Site Status

Hôpital Raymond Poincaré

Garches, , France

Site Status

Hôpital Michallon

Grenoble, , France

Site Status

CHD de la Roche Sur Yon

La Roche-sur-Yon, , France

Site Status

Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Centre Hospitalier du Mans

Le Mans, , France

Site Status

Institut hospitalier franco-britannique

Levallois-Perret, , France

Site Status

Hôpital Dupuytren

Limoges, , France

Site Status

Hôpital de la Croix Rousse

Lyon, , France

Site Status

Hôpital Edouard Herriot

Lyon, , France

Site Status

Hôpital Sainte Marguerite

Marseille, , France

Site Status

Hôpital Européen

Marseille, , France

Site Status

Hôpital Gui de Chauliac

Montpellier, , France

Site Status

Hôpital Emile Müller

Mulhouse, , France

Site Status

Hôpital de l'Hôtel Dieu

Nantes, , France

Site Status

Hôpital de l'Archet

Nice, , France

Site Status

Hôpital Carémeau

Nîmes, , France

Site Status

Hôpital de La Source

Orléans, , France

Site Status

Hôpital Saint-Antoine

Paris, , France

Site Status

Hôpital Necker

Paris, , France

Site Status

Hôpital Bichat

Paris, , France

Site Status

Hôpital de l'Hôtel Dieu

Paris, , France

Site Status

Hôtel-Dieu

Paris, , France

Site Status

Hôpital Saint-Louis

Paris, , France

Site Status

Lariboisière

Paris, , France

Site Status

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Tenon

Paris, , France

Site Status

Centre Hospitalier de Perpignan

Perpignan, , France

Site Status

Centre Hospitalier René Dubos

Pontoise, , France

Site Status

Centre hospitalier Annecy Genevois

Pringy, , France

Site Status

Hôpital Robert Debré

Reims, , France

Site Status

Hôpital Pontchaillou

Rennes, , France

Site Status

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, , France

Site Status

Hôpital Delafontaine

Saint-Denis, , France

Site Status

Hôpital Nord

Saint-Etienne, , France

Site Status

Centre Hospitalier Général de Saint Nazaire

Saint-Nazaire, , France

Site Status

Hôpital Civil

Strasbourg, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Hôpital La Grave

Toulouse, , France

Site Status

Hôpital Purpan

Toulouse, , France

Site Status

Hôpital Gustave Dron

Tourcoing, , France

Site Status

Hôpital Bretonneau

Tours, , France

Site Status

Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Hôpital André Mignot

Versailles, , France

Site Status

Centre Hospitalier Intercommunal

Villeneuve-Saint-Georges, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 35120640 (View on PubMed)

Other Identifiers

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ANRS 170 - QUATUOR

Identifier Type: -

Identifier Source: org_study_id

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