Status:
UNKNOWN
Dual Therapy in HIV Patients in 4 Days a Week Versus 7 Days a Week
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
HIV Infections
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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 vers...
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 ta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04867083
Start Date
June 21 2021
End Date
July 1 2024
Last Update
November 8 2021
Active Locations (38)
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1
Hôpital Louis Pasteur/Service des Maladies Infectieuses
Chartres, Le Coudray, France, 28630
2
Centre hospitalier Victor Dupouy/Service d'Hématologie-Unité d'Immunologie
Argenteuil, France, 95107
3
Hôpital Avicenne/Service des Maladies Infectieuses et tropicales
Bobigny, France, 93009
4
Hôpital Saint André/Service HDJ Maladies Infectieuses
Bordeaux, France, 33075