Dual Therapy in HIV Patients in 4 Days a Week Versus 7 Days a Week

NCT ID: NCT04867083

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2024-07-31

Brief Summary

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.

Detailed Description

Open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non-inferiority of antiretroviral dual therapy taken 4 consecutive days a week versus dual therapy taken 7 days a week, in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral dual therapy since 4 months. The non-inferiority margin (delta) is 5%. The randomization will be stratified according to the family of the dual therapy at the moment of the inclusion and according to the participation of the substudy or not.

The sample size calculation assumes that the true difference in efficacy between the two arms is zero and that the overall response rate is 97% at week 48. A total of 440 patients (220 per arm) is required to provide 80% power to demonstrate non-inferior efficacy for the 4/7 strategy, compared to the daily dual therapy (7/7), with a two-sided significance level of 5% and a non-inferiority margin (delta) of -5%.

Conditions

HIV Infections

Keywords

bitherapy; treatment discontinution; 4 days per week

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: 4 days/7

4 days/7 Patients included in this arm will take their ARV treatment 4 consecutive days per week during 48 weeks.

Group Type: EXPERIMENTAL

ARV bitherapie

Intervention Type: DRUG

1. Dolutégravir 50mg / Lamivudine 300mg per day

2. Dolutégravir 50mg / Rilpivirine 25mg per day

3. Darunavir/r 800mg/100mg / Lamivudine 300mg per day

Arm 2: 7 days/7

Patients included in this arm will take their ARV treatment 7 days per week during 48 weeks

Group Type: ACTIVE_COMPARATOR

ARV bitherapie

Intervention Type: DRUG

1. Dolutégravir 50mg / Lamivudine 300mg per day

2. Dolutégravir 50mg / Rilpivirine 25mg per day

3. Darunavir/r 800mg/100mg / Lamivudine 300mg per day

Interventions

ARV bitherapie

1. Dolutégravir 50mg / Lamivudine 300mg per day

2. Dolutégravir 50mg / Rilpivirine 25mg per day

3. Darunavir/r 800mg/100mg / Lamivudine 300mg per day

Intervention Type: DRUG

Eligibility Criteria

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

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland LANDMAN

Role: PRINCIPAL_INVESTIGATOR

Hôpital BICHAT

Locations

Hôpital Louis Pasteur/Service des Maladies Infectieuses

Chartres, Le Coudray, France

Site Status: RECRUITING

Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'Immunologie

Argenteuil, , France

Site Status: RECRUITING

Hôpital Avicenne/Service des Maladies Infectieuses et tropicales

Bobigny, , France

Site Status: RECRUITING

Hôpital Saint André/Service HDJ Maladies Infectieuses

Bordeaux, , France

Site Status: RECRUITING

Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales

Bordeaux, , France

Site Status: RECRUITING

Hôpital Côte de Nacre/Service des Maladies Infectieuses

Caen, , France

Site Status: RECRUITING

Hôpital Antoine Béclère/Service d'Immunologie Clinique et Médecine Interne

Clamart, , France

Site Status: RECRUITING

Centre Hospitalier Sud-Francilien/Service d'Hématologie

Corbeil-Essonnes, , France

Site Status: RECRUITING

Hôpital François Mitterrand/Service des Maladies Infectieuses

Dijon, , France

Site Status: RECRUITING

Hôpital Raymond Poincaré/Service des Maladies Infectieuses

Garches, , France

Site Status: RECRUITING

CHD de La Roche sur Yon/Service de Médecine Interne

La Roche-sur-Yon, , France

Site Status: RECRUITING

Hôpital Franco-Britannique-Fondation Cognacq-Jay

Levallois-Perret, , France

Site Status: RECRUITING

CHU Dupuytren 1/Service des Maladies Infectieuses et Tropicales

Limoges, , France

Site Status: RECRUITING

Hôpital de la Croix Rousse/Service des Maladies Infectieuses

Lyon, , France

Site Status: RECRUITING

Hôpital Sainte Marguerite/Service d'Immuno-Hématologie Clinique

Marseille, , France

Site Status: RECRUITING

Hôpital Européen/Consultation de Médecine Interne et Maladies Infectieuses

Marseille, , France

Site Status: RECRUITING

Hôpital Gui de Chauliac/Service des Maladies Infectieuses

Montpellier, , France

Site Status: RECRUITING

Hôpital de l'Hôtel Dieu/Service des Maladies Infectieuses

Nantes, , France

Site Status: RECRUITING

Hôpital de l'Archet/Service des Maladies Infectieuses

Nice, , France

Site Status: RECRUITING

Hôpital Bichat/Service des Maladies Infectieuses

Paris, , France

Site Status: RECRUITING

Hôpital Hôtel Dieu/Service d'Immunologie Clinique

Paris, , France

Site Status: RECRUITING

Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse

Paris, , France

Site Status: RECRUITING

Hôpital Lariboisière/Service de Médecine Interne

Paris, , France

Site Status: RECRUITING

Hôpital Saint Louis/Service des Maladies Infectieuses

Paris, , France

Site Status: RECRUITING

Hôpital Saint Antoine/Service des Maladies Infectieuses

Paris, , France

Site Status: RECRUITING

Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses

Paris, , France

Site Status: RECRUITING

Hôpital Necker/Service des Maladies Infectieuses

Paris, , France

Site Status: RECRUITING

Hôpital Tenon/Service des Maladies Infectieuses

Paris, , France

Site Status: RECRUITING

Centre hospitalier de Poissy/Service des Maladies Infectieuses

Poissy, , France

Site Status: RECRUITING

Centre Hospitalier René Dubos/Service de Dermatologie

Pontoise, , France

Site Status: RECRUITING

Hôpital Robert DEBRE/Service des maladies infectieuses

Reims, , France

Site Status: NOT_YET_RECRUITING

Hôpital Delafontaine/Service des Maladies Infectieuses

Saint-Denis, , France

Site Status: RECRUITING

Hôpital Civil/Service Le Trait D'union UF 2066

Strasbourg, , France

Site Status: RECRUITING

Hôpital Foch/Service de Médecine Interne

Suresnes, , France

Site Status: RECRUITING

Hôpital Purpan/Service des Maladies Infectieuses

Toulouse, , France

Site Status: RECRUITING

Hôpital Gustave Dron/Service des Maladies Infectieuses

Tourcoing, , France

Site Status: RECRUITING

Hôpital Bretonneau/Service des Maladies Infectieuses

Tours, , France

Site Status: RECRUITING

Hôpital Pierre Zobda-Quitman/Service de Médecine Interne

Fort-de-France, , Martinique

Site Status: RECRUITING

Countries

France; Martinique

Central Contacts

Karine AMAT

Role: CONTACT

Phone: 0140256352

Email: karine.amat@imea.fr

Aida BENALYCHERIF

Role: CONTACT

Phone: 0140256365

Email: aida.benalycherif@imea.fr

Facility Contacts

Juliana DARASTEANU

Role: primary

Fabienne CABY

Role: primary

Olivier BOUCHAUD

Role: primary

Philippe MORLAT

Role: primary

Didier NEAU

Role: primary

Renaud VERDON

Role: primary

Sophie ABGRALL

Role: primary

Amélie CHABROL

Role: primary

Lionel PIROTH

Role: primary

Pierre DE TRUCHIS

Role: primary

Olivier BOLLENGIER-STRAGIER

Role: primary

Claire GENET

Role: primary

Patrick MIAILHES

Role: primary

Olivia ZAEGEL-FAUCHER

Role: primary

Christina PSOMAS

Role: primary

Jacques REYNES

Role: primary

Clothilde ALLAVENA

Role: primary

Vanessa RIO

Role: primary

Roland LANDMAN

Role: primary

Juliette PAVIE

Role: primary

Dominique SALMON-CERON

Role: primary

Myriam DIEMER

Role: primary

Nathalie DE CASTRO

Role: primary

Karine LACOMBE

Role: primary

Christine KATLAMA

Role: primary

Claudine DUVIVIER

Role: primary

Gilles PIALOUX

Role: primary

Benoit CAZENAVE

Role: primary

Laurent BLUM

Role: primary

Marie-Aude KHUONG-JOSSES

Role: primary

David REY

Role: primary

David ZUCMAN

Role: primary

Pierre DELOBEL

Role: primary

Olivier ROBINEAU

Role: primary

Louis BERNARD

Role: primary

André CABIE

Role: primary

References

Fischer M, Hafner R, Schneider C, Trkola A, Joos B, Joller H, Hirschel B, Weber R, Gunthard HF; Swiss HIV Cohort Study. HIV RNA in plasma rebounds within days during structured treatment interruptions. AIDS. 2003 Jan 24;17(2):195-9. doi: 10.1097/00002030-200301240-00009.

Reference Type: BACKGROUND

PMID: 12545079 (View on PubMed)

Vergis EN, Paterson DL, Wagener MM, Swindells S, Singh N. Dyslipidaemia in HIV-infected patients: association with adherence to potent antiretroviral therapy. Int J STD AIDS. 2001 Jul;12(7):463-8. doi: 10.1258/0956462011923507.

Reference Type: BACKGROUND

PMID: 11394983 (View on PubMed)

Magalhaes MG, Greenberg B, Hansen H, Glick M. Comorbidities in older patients with HIV: a retrospective study. J Am Dent Assoc. 2007 Nov;138(11):1468-75. doi: 10.14219/jada.archive.2007.0083.

Reference Type: BACKGROUND

PMID: 17974644 (View on PubMed)

Ananworanich J, Nuesch R, Cote HC, Kerr SJ, Hill A, Jupimai T, Laopraynak N, Saenawat S, Ruxrungtham K, Hirschel B. Changes in metabolic toxicity after switching from stavudine/didanosine to tenofovir/lamivudine--a Staccato trial substudy. J Antimicrob Chemother. 2008 Jun;61(6):1340-3. doi: 10.1093/jac/dkn097. Epub 2008 Mar 12.

Reference Type: BACKGROUND

PMID: 18339636 (View on PubMed)

Ferry JA, Sohani AR, Longtine JA, Schwartz RA, Harris NL. HHV8-positive, EBV-positive Hodgkin lymphoma-like large B-cell lymphoma and HHV8-positive intravascular large B-cell lymphoma. Mod Pathol. 2009 May;22(5):618-26. doi: 10.1038/modpathol.2009.36. Epub 2009 Mar 13.

Reference Type: BACKGROUND

PMID: 19287457 (View on PubMed)

Ho JE, Hsue PY. Cardiovascular manifestations of HIV infection. Heart. 2009 Jul;95(14):1193-202. doi: 10.1136/hrt.2008.161463. No abstract available.

Reference Type: BACKGROUND

PMID: 19564432 (View on PubMed)

Edelman EJ, Gordon KS, Glover J, McNicholl IR, Fiellin DA, Justice AC. The next therapeutic challenge in HIV: polypharmacy. Drugs Aging. 2013 Aug;30(8):613-28. doi: 10.1007/s40266-013-0093-9.

Reference Type: BACKGROUND

PMID: 23740523 (View on PubMed)

Flandre P, Raffi F, Descamps D, Calvez V, Peytavin G, Meiffredy V, Harel M, Hazebrouck S, Pialoux G, Aboulker JP, Brun Vezinet F. Final analysis of the Trilege induction-maintenance trial: results at 18 months. AIDS. 2002 Mar 8;16(4):561-8. doi: 10.1097/00002030-200203080-00007.

Reference Type: BACKGROUND

PMID: 11872999 (View on PubMed)

Bowersox J. ACTG 343: three drugs better than two for maintaining HIV suppression. NIAID AIDS Agenda. 1998 Mar:1-2, 10-1.

Reference Type: BACKGROUND

PMID: 11365088 (View on PubMed)

Arribas JR, Girard PM, Landman R, Pich J, Mallolas J, Martinez-Rebollar M, Zamora FX, Estrada V, Crespo M, Podzamczer D, Portilla J, Dronda F, Iribarren JA, Domingo P, Pulido F, Montero M, Knobel H, Cabie A, Weiss L, Gatell JM; OLE/RIS-EST13 Study Group. Dual treatment with lopinavir-ritonavir plus lamivudine versus triple treatment with lopinavir-ritonavir plus lamivudine or emtricitabine and a second nucleos(t)ide reverse transcriptase inhibitor for maintenance of HIV-1 viral suppression (OLE): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Jul;15(7):785-92. doi: 10.1016/S1473-3099(15)00096-1. Epub 2015 Jun 7.

Reference Type: BACKGROUND

PMID: 26062880 (View on PubMed)

Perez-Molina JA, Rubio R, Rivero A, Pasquau J, Suarez-Lozano I, Riera M, Estebanez M, Palacios R, Sanz-Moreno J, Troya J, Marino A, Antela A, Navarro J, Esteban H, Moreno S; GeSIDA 7011 Study Group. Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study). J Antimicrob Chemother. 2017 Jan;72(1):246-253. doi: 10.1093/jac/dkw379. Epub 2016 Sep 13.

Reference Type: BACKGROUND

PMID: 27629070 (View on PubMed)

Di Giambenedetto S, Fabbiani M, Quiros Roldan E, Latini A, D'Ettorre G, Antinori A, Castagna A, Orofino G, Francisci D, Chinello P, Madeddu G, Grima P, Rusconi S, Di Pietro M, Mondi A, Ciccarelli N, Borghetti A, Foca E, Colafigli M, De Luca A, Cauda R; Atlas-M Study Group. Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M). J Antimicrob Chemother. 2017 Apr 1;72(4):1163-1171. doi: 10.1093/jac/dkw557.

Reference Type: BACKGROUND

PMID: 28093483 (View on PubMed)

Pulido F, Ribera E, Lagarde M, Perez-Valero I, Palacios R, Iribarren JA, Payeras A, Domingo P, Sanz J, Cervero M, Curran A, Rodriguez-Gomez FJ, Tellez MJ, Ryan P, Barrufet P, Knobel H, Rivero A, Alejos B, Yllescas M, Arribas JR; DUAL-GESIDA-8014-RIS-EST45 Study Group. Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial. Clin Infect Dis. 2017 Nov 29;65(12):2112-2118. doi: 10.1093/cid/cix734.

Reference Type: BACKGROUND

PMID: 29020293 (View on PubMed)

Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6.

Reference Type: BACKGROUND

PMID: 29310899 (View on PubMed)

Katlama C, Assoumou L, Valantin MA, Soulie C, Martinez E, Beniguel L, Bouchaud O, Raffi F, Molina JM, Fellahi S, Peytavin G, Marcelin AG, Kolta S, Capeau J, Gibowski S, Cardon F, Reynes J, Costagliola D; members of the ANRS 163 ETRAL study. Dual therapy combining raltegravir with etravirine maintains a high level of viral suppression over 96 weeks in long-term experienced HIV-infected individuals over 45 years on a PI-based regimen: results from the Phase II ANRS 163 ETRAL study. J Antimicrob Chemother. 2019 Sep 1;74(9):2742-2751. doi: 10.1093/jac/dkz224.

Reference Type: BACKGROUND

PMID: 31269208 (View on PubMed)

Joly V, Burdet C, Landman R, Vigan M, Charpentier C, Katlama C, Cabie A, Benalycherif A, Peytavin G, Yeni P, Mentre F, Argoud AL, Amri I, Descamps D, Yazdanpanah Y; LAMIDOL Study Group. Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL). J Antimicrob Chemother. 2019 Mar 1;74(3):739-745. doi: 10.1093/jac/dky467.

Reference Type: BACKGROUND

PMID: 30476165 (View on PubMed)

Taiwo BO, Marconi VC, Berzins B, Moser CB, Nyaku AN, Fichtenbaum CJ, Benson CA, Wilkin T, Koletar SL, Colasanti J, Acosta EP, Li JZ, Sax PE. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018 May 17;66(11):1794-1797. doi: 10.1093/cid/cix1131.

Reference Type: BACKGROUND

PMID: 29293895 (View on PubMed)

van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.

Reference Type: BACKGROUND

PMID: 31905383 (View on PubMed)

Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9.

Reference Type: BACKGROUND

PMID: 30420123 (View on PubMed)

Dybul M, Chun TW, Yoder C, Hidalgo B, Belson M, Hertogs K, Larder B, Dewar RL, Fox CH, Hallahan CW, Justement JS, Migueles SA, Metcalf JA, Davey RT, Daucher M, Pandya P, Baseler M, Ward DJ, Fauci AS. Short-cycle structured intermittent treatment of chronic HIV infection with highly active antiretroviral therapy: effects on virologic, immunologic, and toxicity parameters. Proc Natl Acad Sci U S A. 2001 Dec 18;98(26):15161-6. doi: 10.1073/pnas.261568398. Epub 2001 Dec 4.

Reference Type: BACKGROUND

PMID: 11734634 (View on PubMed)

Dybul M, Nies-Kraske E, Dewar R, Maldarelli F, Hallahan CW, Daucher M, Piscitelli SC, Ehler L, Weigand A, Palmer S, Metcalf JA, Davey RT, Rock Kress DM, Powers A, Beck I, Frenkel L, Baseler M, Coffin J, Fauci AS. A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine, lamivudine, and efavirenz for the treatment of chronic HIV infection. J Infect Dis. 2004 Jun 1;189(11):1974-82. doi: 10.1086/386344. Epub 2004 May 10.

Reference Type: BACKGROUND

PMID: 15143462 (View on PubMed)

Cohen CJ, Colson AE, Sheble-Hall AG, McLaughlin KA, Morse GD. Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five-days-on, two-days-off (FOTO) study. HIV Clin Trials. 2007 Jan-Feb;8(1):19-23. doi: 10.1310/hct0801-19.

Reference Type: BACKGROUND

PMID: 17434845 (View on PubMed)

Cohen C, Colson A, Pierone G. The FOTO study: Twenty-Four week results support the safety of a two day break on efavirenz-based antiretroviral therapy. Presented at: Ninth International Congress on Drug Therapy in HIV Infection; November 8-13, 2008; Glasgow, UK

Reference Type: BACKGROUND

Cohen C, Colson A, Pierone G, et al. The FOTO study: The 48 week extension to assess durability of the strategy of taking efavirenz, tenofovir and emtricitabine Five days On, Two days Off (FOTO) each week in virologically suppressed patients. Presented at: Fifth International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention; July 19-22, 2009; Cape Town, South Africa

Reference Type: BACKGROUND

Reynolds SJ, Kityo C, Hallahan CW, Kabuye G, Atwiine D, Mbamanya F, Ssali F, Dewar R, Daucher M, Davey RT Jr, Mugyenyi P, Fauci AS, Quinn TC, Dybul MR. A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda. PLoS One. 2010 Apr 22;5(4):e10307. doi: 10.1371/journal.pone.0010307.

Reference Type: BACKGROUND

PMID: 20442758 (View on PubMed)

Leibowitch J, Mathez D, de Truchis P, Ledu D, Melchior JC, Carcelain G, Izopet J, Perronne C, David JR. Four days a week or less on appropriate anti-HIV drug combinations provided long-term optimal maintenance in 94 patients: the ICCARRE project. FASEB J. 2015 Jun;29(6):2223-34. doi: 10.1096/fj.14-260315. Epub 2015 Apr 1.

Reference Type: BACKGROUND

PMID: 25833895 (View on PubMed)

BREATHER (PENTA 16) Trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial. Lancet HIV. 2016 Sep;3(9):e421-e430. doi: 10.1016/S2352-3018(16)30054-6. Epub 2016 Jun 20.

Reference Type: BACKGROUND

PMID: 27562743 (View on PubMed)

de Truchis P, Assoumou L, Landman R, Mathez D, Le Du D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.

Reference Type: BACKGROUND

PMID: 29186458 (View on PubMed)

R. Landman, P. De Truchis, L. Assoumou, S. Lambert, K. Amat, J. Bellet, B. Lefebvre, C. Allavena, C. Katlama, Y. Yazdanpanah, J.-M. Molina, A. Gelley, S. Gibowski, J.-C. Alvarez, L. Morand-Joubert, D. Costagliola, P.-M. Girard, ANRS 170 QUATUOR study group -ANRS 170 QUATUOR 4/7 days maintenance strategy in antiretroviral treated adults with HIV-1 infection: an open randomised parallel non-inferiority phase III trial Abstract IAS2019 WEAB0406LB

Reference Type: BACKGROUND

Parienti JJ, Das-Douglas M, Massari V, Guzman D, Deeks SG, Verdon R, Bangsberg DR. Not all missed doses are the same: sustained NNRTI treatment interruptions predict HIV rebound at low-to-moderate adherence levels. PLoS One. 2008 Jul 30;3(7):e2783. doi: 10.1371/journal.pone.0002783.

Reference Type: BACKGROUND

PMID: 18665246 (View on PubMed)

Pogany K, van Valkengoed IG, Prins JM, Nieuwkerk PT, van der Ende I, Kauffmann RH, Kroon FP, Verbon A, Nievaard MF, Lange JM, Brinkman K. Effects of active treatment discontinuation in patients with a CD4+ T-cell nadir greater than 350 cells/mm3: 48-week Treatment Interruption in Early Starters Netherlands Study (TRIESTAN). J Acquir Immune Defic Syndr. 2007 Apr 1;44(4):395-400. doi: 10.1097/QAI.0b013e31802f83bc.

Reference Type: BACKGROUND

PMID: 17195761 (View on PubMed)

Zehnacker L, Abe E, Mathez D, Alvarez JC, Leibowitch J, Azoulay S. Plasma and Intracellular Antiretroviral Concentrations in HIV-Infected Patients under Short Cycles of Antiretroviral Therapy. AIDS Res Treat. 2014;2014:724958. doi: 10.1155/2014/724958. Epub 2014 Nov 9.

Reference Type: BACKGROUND

PMID: 25431661 (View on PubMed)

Other Identifiers

2020-003951-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ANRS 177 DUETTO

Identifier Type: -

Identifier Source: org_study_id