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

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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