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

ANRS, Emerging Infectious Diseases

Status and phase: Enrolling; Phase 3

Conditions: HIV Infections

Treatments: Drug: ARV bitherapie

Study type: Interventional

Funder types: Other

Identifiers

NCT04867083

2020-003951-13 (EudraCT Number)

ANRS 177 DUETTO

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 440 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

Arm 1: 4 days/7

Experimental group

Description:

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

Treatment:

Drug: ARV bitherapie

Arm 2: 7 days/7

Active Comparator group

Description:

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

Treatment:

Drug: ARV bitherapie