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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Treatment discontinuation
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Controlled, virological and therapeutic success, treatment discontinution, 4 days per week

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Pointe-à-Pitre
  • Hôpital La Meynard Zobda Quitman
  • Centre hospitalier Victor Dupouy
  • Hôpital Henri Duffaut
  • CHRU Jean Minjoz
  • Avicenne
  • Jean Verdier
  • Hôpital Saint-André
  • Hôpital Pellegrin
  • Hôpital Ambroise Paré
  • Hôpital de la Côte de Nacre
  • Hôpital Louis Pasteur
  • Antoine Beclère
  • Hôpital Gabriel Montpied
  • Centre hospitalier sud francilien
  • CHI de Créteil
  • Hôpital Henri Mondor
  • Hôpital du Bocage
  • Hôpital Raymond Poincaré
  • Hôpital Michallon
  • Bicêtre
  • CHD de la Roche Sur Yon
  • Centre Hospitalier du Mans
  • Institut hospitalier franco-britannique
  • Hôpital Dupuytren
  • Hôpital de la Croix Rousse
  • Hôpital Edouard Herriot
  • Hôpital Sainte Marguerite
  • Hôpital Européen
  • Hôpital Gui de Chauliac
  • Hôpital Emile Müller
  • Hôpital de l'Hôtel Dieu
  • Hôpital de l'Archet
  • Hôpital Carémeau
  • Hôpital de La Source
  • Hôpital Saint-Antoine
  • Hôpital Necker
  • Hôpital Bichat
  • Hôpital de l'Hôtel Dieu
  • Hôtel-Dieu
  • Hôpital Saint-Louis
  • Lariboisière
  • Hôpital Pitié-Salpêtrière
  • Hôpital Européen Georges Pompidou
  • Tenon
  • Centre Hospitalier de Perpignan
  • Centre Hospitalier René Dubos
  • Centre hospitalier Annecy Genevois
  • Hôpital Robert Debré
  • Hôpital Pontchaillou
  • Centre Hospitalier de Saint-Brieuc
  • Hôpital Delafontaine
  • Centre Hospitalier Général de Saint Nazaire
  • Hôpital Nord
  • Hôpital Civil
  • Hôpital Foch
  • Hôpital La Grave
  • Hôpital Purpan
  • Hôpital Gustave Dron
  • Hôpital Bretonneau
  • Hôpital de Brabois
  • Hôpital André Mignot
  • Centre Hospitalier Intercommunal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4 days / 7

7 days / 7

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Virological success
The HIV-1 viral load at week 48 must be inferior to 50 copies/mL
Number of virological " blips "
viral load > 50 copies/mL followed by a control value ≤ 50 cp/mL
Percentage of patients with a viral load signal detected
(subgroup of patients tested with Roche-Taqman, threshold<20 copies/mL)
Proportion of patients with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by next generation sequencing
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
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
Description of the factors associated with virological rebound (viral load >50 cp/mL).
(viral load >50 cp/mL).
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
Evolution of fasting metabolic parameters
Measurement of total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia
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
HIV RNA viral load in semen
Sperm sub-study (120 patients)
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)
Residual plasmatic concentrations of tenofovir (TDF or TAF)
Measurement of tenofovir plasmatic concentration
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)
Treatment adherence
Evaluation by a self-reported questionnaire
Quality of life
Evaluation by a self-reported questionnaire
Patient satisfaction
Evaluation by a self-reported questionnaire
Pharmaco-economic aspects of the strategy
Assessment and comparison of cost essay between each arm.
Median time to virologic failure
Measure the delay between week 0 and the date of different virologic failure
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

Full Information

First Posted
August 9, 2017
Last Updated
February 2, 2018
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
IMEA Leon M'Ba Foundation, Unit 1136 INSERM, Faculty of medecine, University Pierre and Marie Curie
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1. Study Identification

Unique Protocol Identification Number
NCT03256422
Brief Title
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
Acronym
QUATUOR
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
IMEA Leon M'Ba Foundation, Unit 1136 INSERM, Faculty of medecine, University Pierre and Marie Curie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Controlled, virological and therapeutic success, treatment discontinution, 4 days per week

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label, randomized trial in 2 parallel groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 days / 7
Arm Type
Experimental
Arm Description
Patients included in this arm will take their ARV treatment 4 consecutive days per week during 98 weeks
Arm Title
7 days / 7
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Treatment discontinuation
Intervention Description
• Receiving tritherapy. Allowed treatment drugs are : nucleoside analogs : tenofovir (TDF ou TAF), emtricitabine, abacavir, lamivudine protease inhibitors : lopinavir/r, darunavir/r ou atazanavir/r non nucleoside reverse transcriptase inhibitors : efavirenz, rilpivirine ou etravirine integrase inhibitors : dolutegravir, elvitegravir/cobicistat ou raltegravir
Primary Outcome Measure Information:
Title
Proportion of patients with therapeutic success at Week 48.
Description
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.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Proportion of patients with therapeutic success at Week 96
Description
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.
Time Frame
Week 96
Title
Virological success
Description
The HIV-1 viral load at week 48 must be inferior to 50 copies/mL
Time Frame
Week 48 and Week 96
Title
Number of virological " blips "
Description
viral load > 50 copies/mL followed by a control value ≤ 50 cp/mL
Time Frame
between Week 0 and Week 48, and between Week 0 and Week 96
Title
Percentage of patients with a viral load signal detected
Description
(subgroup of patients tested with Roche-Taqman, threshold<20 copies/mL)
Time Frame
between Week 0 and Week 48 and Week 0 and Week 96
Title
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)
Title
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
Title
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)
Description
Immuno-viro-pharmacological sub-study of 120 patients
Time Frame
between Week 0, Week 48 and Week 96
Title
Description of the factors associated with virological rebound (viral load >50 cp/mL).
Description
(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)
Title
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
Description
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
Time Frame
from Week-4 to Week 48 and Week 96
Title
Evolution of fasting metabolic parameters
Description
Measurement of total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia
Time Frame
until Week 48 and Week 96
Title
Evolution of inflammation and immune activation parameters
Description
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
Time Frame
from Week 0 to Week 24 and Week 48
Title
HIV RNA viral load in semen
Description
Sperm sub-study (120 patients)
Time Frame
Week 0, Week 24 and Week 48
Title
Residual plasmatic concentrations of the third antiretroviral agent
Description
Measurement of the third antiretroviral agent plasmatic concentration (protease inhibitors or non-nucleoside reverse transcriptase inhibitors or integrase inhibitors)
Time Frame
Week 0, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96
Title
Residual plasmatic concentrations of tenofovir (TDF or TAF)
Description
Measurement of tenofovir plasmatic concentration
Time Frame
Week 0, Week 4, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96
Title
Residual intracellular concentrations of the third antiretroviral agents
Description
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)
Time Frame
Week 0, Week 24 and Week 48
Title
Treatment adherence
Description
Evaluation by a self-reported questionnaire
Time Frame
Week 0, Week 12, Week 24, Week 36, Week 48, Week 72,and Week 96
Title
Quality of life
Description
Evaluation by a self-reported questionnaire
Time Frame
Week-4, Week 0, Week 48 and Week 96
Title
Patient satisfaction
Description
Evaluation by a self-reported questionnaire
Time Frame
Week 0, Week 12, Week 48 and Week 96
Title
Pharmaco-economic aspects of the strategy
Description
Assessment and comparison of cost essay between each arm.
Time Frame
Between Week 0 and Week 98
Title
Median time to virologic failure
Description
Measure the delay between week 0 and the date of different virologic failure
Time Frame
Between week 0 and 98
Title
Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE)
Description
according to the sponsor's grading scale
Time Frame
Between Week 0 and Week 98

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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). 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre De Truchis, MD
Organizational Affiliation
Hôpital Raymond Poincaré
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Pointe-à-Pitre
City
Pointe-à-Pitre
State/Province
Guadeloupe
ZIP/Postal Code
97159
Country
France
Facility Name
Hôpital La Meynard Zobda Quitman
City
Fort-de-France
State/Province
Martinique
ZIP/Postal Code
97261
Country
France
Facility Name
Centre hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Hôpital Henri Duffaut
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
CHRU Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Jean Verdier
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
Hôpital Saint-André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital Ambroise Paré
City
Boulogne-Billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
Hôpital de la Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Louis Pasteur
City
Chartres
ZIP/Postal Code
28630
Country
France
Facility Name
Antoine Beclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Centre hospitalier sud francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
CHI de Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hôpital Raymond Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Hôpital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Bicêtre
City
Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
CHD de la Roche Sur Yon
City
La Roche-sur-Yon
ZIP/Postal Code
85295
Country
France
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Institut hospitalier franco-britannique
City
Levallois-Perret
ZIP/Postal Code
92309
Country
France
Facility Name
Hôpital Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hôpital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Hôpital Européen
City
Marseille
ZIP/Postal Code
13331
Country
France
Facility Name
Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Emile Müller
City
Mulhouse
Country
France
Facility Name
Hôpital de l'Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital de l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital de La Source
City
Orléans
ZIP/Postal Code
45100
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hôpital de l'Hôtel Dieu
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hôtel-Dieu
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Centre Hospitalier de Perpignan
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Centre Hospitalier René Dubos
City
Pontoise
ZIP/Postal Code
95301
Country
France
Facility Name
Centre hospitalier Annecy Genevois
City
Pringy
ZIP/Postal Code
74374
Country
France
Facility Name
Hôpital Robert Debré
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier de Saint-Brieuc
City
Saint-Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Hôpital Delafontaine
City
Saint-Denis
ZIP/Postal Code
93205
Country
France
Facility Name
Centre Hospitalier Général de Saint Nazaire
City
Saint-Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Hôpital Nord
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Facility Name
Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Hôpital La Grave
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital Gustave Dron
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Hôpital de Brabois
City
Vandoeuvre les Nancy cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Hôpital André Mignot
City
Versailles
ZIP/Postal Code
78157
Country
France
Facility Name
Centre Hospitalier Intercommunal
City
Villeneuve-Saint-Georges
ZIP/Postal Code
94195
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35120640
Citation
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. Erratum In: Lancet HIV. 2022 Feb 22;:
Results Reference
derived

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

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