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

NCT04867083 | Unknown Phase 3 DMC

• 2 other identifiers: ANRS 177 DUETTO2020-003951-13
• Study Type: interventional
• Target: 440
• Locations: 2 countries
• Sites: 38

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.

Conditions

HIV Infections

Keywords

bitherapy; treatment discontinution; 4 days per week

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with virological failure at Week 48.

  The virological failure is defined by 2 successive viral loads \>50 c/mL at 2 to 4 weeks apart or a viral load \> 50 c/ml with a definitive stop of the study follow-up or the study strategy

  Week 48

Secondary Outcomes (16)

• Proportion of participants with therapeutic success until Week 48

  Week 48

• Percentage of participants with at least one episode of "blip"

  Week 0 to Week48

• Percentage of participants with a viral load signal detected

  Week 0 to Week 48

• Evolution of ultrasensitive viral load and total DNA in the PBMC at W0 and W48

  Week 0 and Week 48

• Proportion of participants with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by NGS

  Week 0 to Week 48

Study Arms (2)

Arm 1: 4 days/7

EXPERIMENTAL

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

Drug: ARV bitherapie

Arm 2: 7 days/7

ACTIVE COMPARATOR

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

Drug: ARV bitherapie

Interventions

ARV bitherapie 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 1: 4 days/7; Arm 2: 7 days/7

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (38)

Hôpital Louis Pasteur/Service des Maladies Infectieuses

Chartres, Le Coudray, 28630, France

RECRUITING

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

Argenteuil, 95107, France

RECRUITING

Hôpital Avicenne/Service des Maladies Infectieuses et tropicales

Bobigny, 93009, France

RECRUITING

Hôpital Saint André/Service HDJ Maladies Infectieuses

Bordeaux, 33075, France

RECRUITING

Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales

Bordeaux, 33076, France

RECRUITING

Hôpital Côte de Nacre/Service des Maladies Infectieuses

Caen, 14033, France

RECRUITING

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

Clamart, 92141, France

RECRUITING

Centre Hospitalier Sud-Francilien/Service d'Hématologie

Corbeil-Essonnes, 91106, France

RECRUITING

Hôpital François Mitterrand/Service des Maladies Infectieuses

Dijon, 21079, France

RECRUITING

Hôpital Raymond Poincaré/Service des Maladies Infectieuses

Garches, 92380, France

RECRUITING

CHD de La Roche sur Yon/Service de Médecine Interne

La Roche-sur-Yon, 85925, France

RECRUITING

Hôpital Franco-Britannique-Fondation Cognacq-Jay

Levallois-Perret, 92300, France

RECRUITING

CHU Dupuytren 1/Service des Maladies Infectieuses et Tropicales

Limoges, 87042, France

RECRUITING

Hôpital de la Croix Rousse/Service des Maladies Infectieuses

Lyon, 69317, France

RECRUITING

Hôpital Sainte Marguerite/Service d'Immuno-Hématologie Clinique

Marseille, 13274, France

RECRUITING

Hôpital Européen/Consultation de Médecine Interne et Maladies Infectieuses

Marseille, 13331, France

RECRUITING

Hôpital Gui de Chauliac/Service des Maladies Infectieuses

Montpellier, 34295, France

RECRUITING

Hôpital de l'Hôtel Dieu/Service des Maladies Infectieuses

Nantes, 44093, France

RECRUITING

Hôpital de l'Archet/Service des Maladies Infectieuses

Nice, 06202, France

RECRUITING

Hôpital Bichat/Service des Maladies Infectieuses

Paris, 75018, France

RECRUITING

Hôpital Hôtel Dieu/Service d'Immunologie Clinique

Paris, 75181, France

RECRUITING

Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse

Paris, 75181, France

RECRUITING

Hôpital Lariboisière/Service de Médecine Interne

Paris, 75475, France

RECRUITING

Hôpital Saint Louis/Service des Maladies Infectieuses

Paris, 75475, France

RECRUITING

Hôpital Saint Antoine/Service des Maladies Infectieuses

Paris, 75571, France

RECRUITING

Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses

Paris, 75651, France

RECRUITING

Hôpital Necker/Service des Maladies Infectieuses

Paris, 75743, France

RECRUITING

Hôpital Tenon/Service des Maladies Infectieuses

Paris, 75970, France

RECRUITING

Centre hospitalier de Poissy/Service des Maladies Infectieuses

Poissy, 78300, France

RECRUITING

Centre Hospitalier René Dubos/Service de Dermatologie

Pontoise, 95301, France

RECRUITING

Hôpital Robert DEBRE/Service des maladies infectieuses

Reims, 51092, France

NOT YET RECRUITING

Hôpital Delafontaine/Service des Maladies Infectieuses

Saint-Denis, 93205, France

RECRUITING

Hôpital Civil/Service Le Trait D'union UF 2066

Strasbourg, 67091, France

RECRUITING

Hôpital Foch/Service de Médecine Interne

Suresnes, 92151, France

RECRUITING

Hôpital Purpan/Service des Maladies Infectieuses

Toulouse, 31059, France

RECRUITING

Hôpital Gustave Dron/Service des Maladies Infectieuses

Tourcoing, 59208, France

RECRUITING

Hôpital Bretonneau/Service des Maladies Infectieuses

Tours, 37044, France

RECRUITING

Hôpital Pierre Zobda-Quitman/Service de Médecine Interne

Fort-de-France, 97261, Martinique

RECRUITING

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MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Roland LANDMAN

  Hôpital BICHAT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine AMAT

CONTACT

0140256352; karine.amat@imea.fr

Aida BENALYCHERIF

CONTACT

0140256365; aida.benalycherif@imea.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Open-label, multicenter, prospective, randomized trial in 2 parallel groups

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 30, 2021
• Study Start: June 21, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); FR (37)