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