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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867083
• Other study ID #: ANRS 177 DUETTO
• Secondary ID: 2020-003951-13
• Status: Recruiting
• Phase: Phase 3
• Start date: June 21, 2021
• Est. completion date: July 2024

Study information

• Verified date: November 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: Karine AMAT
• Phone: 0140256352
• Email: karine.amat[@]imea.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: July 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• ARV bitherapie
Dolutégravir 50mg / Lamivudine 300mg per day Dolutégravir 50mg / Rilpivirine 25mg per day Darunavir/r 800mg/100mg / Lamivudine 300mg per day

Locations

Country	Name	City	State
France	Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'Immunologie	Argenteuil Cedex
France	Hôpital Avicenne/Service des Maladies Infectieuses et tropicales	Bobigny cedex
France	Hôpital Pellegrin/Service des Maladies Infectieuses et Tropicales	Bordeaux cedex
France	Hôpital Saint André/Service HDJ Maladies Infectieuses	Bordeaux cedex
France	Hôpital Côte de Nacre/Service des Maladies Infectieuses	Caen cedex 9
France	Hôpital Louis Pasteur/Service des Maladies Infectieuses	Chartres	Le Coudray
France	Hôpital Antoine Béclère/Service d'Immunologie Clinique et Médecine Interne	Clamart cedex
France	Centre Hospitalier Sud-Francilien/Service d'Hématologie	Corbeil-Essonnes cedex
France	Hôpital François Mitterrand/Service des Maladies Infectieuses	Dijon cedex
France	Hôpital Raymond Poincaré/Service des Maladies Infectieuses	Garches
France	CHD de La Roche sur Yon/Service de Médecine Interne	La Roche sur Yon cedex 9
France	Hôpital Franco-Britannique-Fondation Cognacq-Jay	Levallois-Perret
France	CHU Dupuytren 1/Service des Maladies Infectieuses et Tropicales	Limoges
France	Hôpital de la Croix Rousse/Service des Maladies Infectieuses	Lyon cedex 4
France	Hôpital Européen/Consultation de Médecine Interne et Maladies Infectieuses	Marseille cedex 01
France	Hôpital Sainte Marguerite/Service d'Immuno-Hématologie Clinique	Marseille cedex 9
France	Hôpital Gui de Chauliac/Service des Maladies Infectieuses	Montpellier cedex 5
France	Hôpital de l'Hôtel Dieu/Service des Maladies Infectieuses	Nantes cedex 1
France	Hôpital de l'Archet/Service des Maladies Infectieuses	Nice cedex 3
France	Hôpital Bichat/Service des Maladies Infectieuses	Paris
France	Hôpital Lariboisière/Service de Médecine Interne	Paris cedex 10
France	Hôpital Saint Louis/Service des Maladies Infectieuses	Paris cedex 10
France	Hôpital Saint Antoine/Service des Maladies Infectieuses	Paris cedex 12
France	Hôpital Pitié-Salpêtrière/Service des Maladies Infectieuses	Paris cedex 13
France	Hôpital Necker/Service des Maladies Infectieuses	Paris cedex 15
France	Hôpital Tenon/Service des Maladies Infectieuses	Paris cedex 20
France	Hôpital Hôtel Dieu/Service d'Immunologie Clinique	Paris cedex 4
France	Hôpital Hôtel Dieu/Unité fonctionnelle de Pathologie Infectieuse	Paris cedex 4
France	Centre hospitalier de Poissy/Service des Maladies Infectieuses	Poissy
France	Centre Hospitalier René Dubos/Service de Dermatologie	Pontoise
France	Hôpital Robert DEBRE/Service des maladies infectieuses	Reims cedex
France	Hôpital Delafontaine/Service des Maladies Infectieuses	Saint Denis cedex 1
France	Hôpital Civil/Service Le Trait D'union UF 2066	Strasbourg Cedex
France	Hôpital Foch/Service de Médecine Interne	Suresnes
France	Hôpital Purpan/Service des Maladies Infectieuses	Toulouse cedex
France	Hôpital Gustave Dron/Service des Maladies Infectieuses	Tourcoing cedex
France	Hôpital Bretonneau/Service des Maladies Infectieuses	Tours
Martinique	Hôpital Pierre Zobda-Quitman/Service de Médecine Interne	Fort-de-France

Sponsors (2)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  Martinique, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of participants with therapeutic success until Week 48		Week 48
Secondary	Percentage of participants with at least one episode of "blip"	viral load >50 copies/mL followed by a control value = 50 cp/mL	Week 0 to Week48
Secondary	Percentage of participants with a viral load signal detected		Week 0 to Week 48
Secondary	Evolution of ultrasensitive viral load and total DNA in the PBMC at W0 and W48	immuno-virological sub-study	Week 0 and Week 48
Secondary	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
Secondary	Description of selected mutations at the virological failure		Week 0 to Week 48
Secondary	Frequency of minority resistant variants archived in DNA at W0 and their impact on virological failure (2 consecutive VL> 50 copies / mL) and on the acquisition of drugs resistance mutations		Week 0
Secondary	Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE)		Week 0 to Week 48
Secondary	Evolution of T CD4 and CD8 cells count, and CD4/CD8 ratio		Week-4 to Week 48
Secondary	Evolution of fasting metabolic parameters (total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia) until W0 and W48		Week 0 to Week 48
Secondary	Evolution of weight between Week 0 and Week 48		Week 0 and Week 48
Secondary	Evolution of inflammation serum parameters	immuno-virological sub-study- (sCD14, sCD163, IP-10, CRPus, IL-6, D-dimers, sTNFR1, sTNFR2) from W0 to W24 and W48	Week 0 to Week 24 and Week 48
Secondary	Evolution of semen viral load at Week 0, Week 24 and Week 48	Sub-study	Week 0-Week 24 and Week 48
Secondary	Description and comparison of plasmatic concentrations of antiretroviral agents between the 2 groups at ON and OFF period		Week 0-Week 8-Week 24-Week 48
Secondary	Evaluation of the adherence by self-reported questionnaire		At Week 0, Week 8, Week 24, Week 36 and Week 48-the evaluation will be done after analysis of all the points
Secondary	Evolution of the quality of life by self-reported questionnaire		Week-4 to Week 48-the evaluation will be done after analysis of all the points