Informations générales (source: ClinicalTrials.gov)
Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Dual Therapy
Interventional
Phase 3
ANRS, Emerging Infectious Diseases (Voir sur ClinicalTrials)
juin 2021
juillet 2024
19 octobre 2024
The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel
groups, evaluating at W48 the non inferiority of antiretroviral dual therapy taken 4
consecutive days per week versus antiretroviral dual therapy 7/7 days per week in HIV-1
infected patients with controlled viral load under antiretroviral dual therapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | DAVID ZUCMAN | 21/10/2024 07:07:21 | Contacter | ||
| HOPITAL NOVO | BLUM | 04/07/2024 11:04:55 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Olivier BOUCHAUD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Bichat | Roland LANDMAN | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Claudine DUVIVIER | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Karine LACOMBE | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Gilles PIALOUX | Contact (sur clinicalTrials) | |||
| CHI POISSY ST-GERMAIN | Benoit CAZENAVE | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'Immunologie - 95107 - Argenteuil Cedex - France | Fabienne CABY | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Sud-Francilien/Service d'Hématologie - 91106 - Corbeil-Essonnes cedex - France | Amélie CHABROL | Contact (sur clinicalTrials) | |||
| CHD de La Roche sur Yon/Service de Médecine Interne - 85925 - La Roche sur Yon cedex 9 - France | Olivier BOLLENGIER-STRAGIER | Contact (sur clinicalTrials) | |||
| CHU Dupuytren 1/Service des Maladies Infectieuses et Tropicales - 87042 - Limoges - France | Claire GENET | Contact (sur clinicalTrials) | |||
| Hôpital Antoine Béclère/Service d'Immunologie Clinique et Médecine Interne - 92141 - Clamart cedex - France | Sophie ABGRALL | Contact (sur clinicalTrials) | |||
| Hôpital Bretonneau/Service des Maladies Infectieuses - 37044 - Tours - France | Louis BERNARD | Contact (sur clinicalTrials) | |||
| Hôpital Civil/Service Le Trait D'union UF 2066 - 67091 - Strasbourg Cedex - France | David REY | Contact (sur clinicalTrials) | |||
| Hôpital Côte de Nacre/Service des Maladies Infectieuses - 14033 - Caen cedex 9 - France | Renaud VERDON | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Rousse/Service des Maladies Infectieuses - 69317 - Lyon cedex 4 - France | Patrick MIAILHES | Contact (sur clinicalTrials) | |||
| Hôpital de l'Archet/Service des Maladies Infectieuses - 06202 - Nice cedex 3 - France | Vanessa RIO | Contact (sur clinicalTrials) | |||
| Hôpital de l'Hôtel Dieu/Service des Maladies Infectieuses - 44093 - Nantes cedex 1 - France | Clothilde ALLAVENA | Contact (sur clinicalTrials) | |||
| Hôpital Delafontaine/Service des Maladies Infectieuses - 93205 - Saint Denis cedex 1 - France | Marie-Aude KHUONG-JOSSES | Contact (sur clinicalTrials) | |||
| Hôpital Européen/Consultation de Médecine Interne et Maladies Infectieuses - 13331 - Marseille cedex 01 - France | Christina PSOMAS | Contact (sur clinicalTrials) | |||
| Hôpital Franco-Britannique-Fondation Cognacq-Jay - 92300 - Levallois-Perret - France | Contact (sur clinicalTrials) | ||||
| Hôpital François Mitterrand/Service des Maladies Infectieuses - 21079 - Dijon cedex - France | Lionel PIROTH | Contact (sur clinicalTrials) | |||
| Hôpital Gui de Chauliac/Service des Maladies Infectieuses - 34295 - Montpellier cedex 5 - France | Jacques REYNES | Contact (sur clinicalTrials) | |||
| Hôpital Gustave Dron/Service des Maladies Infectieuses - 59208 - Tourcoing cedex - France | Olivier ROBINEAU | Contact (sur clinicalTrials) | |||
| Hôpital Hôtel Dieu/Service d'Immunologie Clinique - 75181 - Paris cedex 4 - France | Juliette PAVIE | Contact (sur clinicalTrials) | |||
| Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse - 75181 - Paris cedex 4 - France | Dominique SALMON-CERON | Contact (sur clinicalTrials) | |||
| Hôpital Lariboisière/Service de Médecine Interne - 75475 - Paris cedex 10 - France | Myriam DIEMER | Contact (sur clinicalTrials) | |||
| Hôpital Louis Pasteur/Service des Maladies Infectieuses - 28630 - Chartres - Le Coudray - France | Juliana DARASTEANU | Contact (sur clinicalTrials) | |||
| Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales - 33076 - Bordeaux cedex - France | Didier NEAU | Contact (sur clinicalTrials) | |||
| Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses - 75651 - Paris cedex 13 - France | Christine KATLAMA | Contact (sur clinicalTrials) | |||
| Hôpital Purpan/Service des Maladies Infectieuses - 31059 - Toulouse cedex - France | Pierre DELOBEL | Contact (sur clinicalTrials) | |||
| Hôpital Raymond Poincaré/Service des Maladies Infectieuses - 92380 - Garches - France | Pierre DE TRUCHIS | Contact (sur clinicalTrials) | |||
| Hôpital Robert DEBRE/Service des maladies infectieuses - 51092 - Reims cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint André/Service HDJ Maladies Infectieuses - 33075 - Bordeaux cedex - France | Philippe MORLAT | Contact (sur clinicalTrials) | |||
| Hôpital Saint Louis/Service des Maladies Infectieuses - 75475 - Paris cedex 10 - France | Nathalie DE CASTRO | Contact (sur clinicalTrials) | |||
| Hôpital Sainte Marguerite/Service d'Immuno-Hématologie Clinique - 13274 - Marseille cedex 9 - France | Olivia ZAEGEL-FAUCHER | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- HIV-1 infection, coinfection HIV-1/HIV-2 possible
- Age≥18 years old
- Current dual therapy unchanged for the last 6 months with Dolutegravir/ Lamivudine
or Dolutegravir / Rilpivirine or Darunavir/r / Lamivudine
- If a genotype is available in the patient medical history; virus must be susceptible
to all on going dual therapy. If no ARN genotype available, the patients can be
included in the study
- Viral load (VL) < 50 c/mL in the past twelve months, with at least 3 VL measurements
including screening; only one blip < 200 c/mL is authorized in the 6-12 previous
months
- CD4 T cells > 250/mm3 at W-4
- Estimated glomerular filtration rate > 60 mL/min (CKD-EPI method)
- AST et ALT < 3N
- Haemoglobin > 10 g/dL
- Platelets > 100 000/mm3
- For women of childbearing age, negative pregnancy plasmatic test at W-4 and agree to
use efficacy contraception during the study
- Commitment to use condom prevention and protection during sexual intercourse for the
duration of the trial.
- Social security system coverage (including State Medical Aid-AME, if EC approves it)
- Informed consent form signed
- HIV-1 infection, coinfection HIV-1/HIV-2 possible
- Age≥18 years old
- Current dual therapy unchanged for the last 6 months with Dolutegravir/ Lamivudine
or Dolutegravir / Rilpivirine or Darunavir/r / Lamivudine
- If a genotype is available in the patient medical history; virus must be susceptible
to all on going dual therapy. If no ARN genotype available, the patients can be
included in the study
- Viral load (VL) < 50 c/mL in the past twelve months, with at least 3 VL measurements
including screening; only one blip < 200 c/mL is authorized in the 6-12 previous
months
- CD4 T cells > 250/mm3 at W-4
- Estimated glomerular filtration rate > 60 mL/min (CKD-EPI method)
- AST et ALT < 3N
- Haemoglobin > 10 g/dL
- Platelets > 100 000/mm3
- For women of childbearing age, negative pregnancy plasmatic test at W-4 and agree to
use efficacy contraception during the study
- Commitment to use condom prevention and protection during sexual intercourse for the
duration of the trial.
- Social security system coverage (including State Medical Aid-AME, if EC approves it)
- Informed consent form signed
- 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 48 weeks
- Concomitant treatment using interferon, interleukins, any other immune-therapy or
chemotherapy, antivitamin K+ with co-treatment by 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