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Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients

CompletedPhase 3

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: HIV Infections

Interventions: Treatment discontinuation

Countries: France

The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48, the non-inferiority of antiretroviral treatment taken 4 consecutive days a week versus continuous therapy, in HIV infected patients with controlled viral load for at least 12 months and stable antiretroviral treatment since 4 months.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* HIV-1 infection, coinfection HIV-1/HIV-2 possible
* Age≥18 years old
* Current therapy unchanged for the last 4 months
* Receiving tritherapy with 2 nucleoside reverse transcriptase inhibitor+protease inhibitors or 2 nucleoside reverse transcriptase inhibitor+non-nucleoside reverse transcriptase inhibitors or 2 nucleoside reverse transcriptase inhibitor+integrase inhibitors.

Allowed treatment drugs are :

1\. nucleoside analogs : tenofovir (TDF ou TAF), emtricitabine, abacavir, lamivudine 2. protease inhibitors : lopinavir/r, darunavir/r ou atazanavir/r 3. Non nucleoside reverse transcriptase inhibitors : efavirenz, rilpivirine ou etravirine 4. integrase inhibitors : dolutegravir, elvitegravir/cobicistat ou raltegravir

* Viruses susceptible to all antiretroviral drugs present in the ongoing tritherapy (AC11-ANRS algorithm).

  1. If a genotype is available in the patient medical history; viruses must be susceptible to all ongoing antiretroviral drugs
  2. If no RNA genotype available, a genotype will be performed on DNA at screening and will not have to show any resistance to the ongoing antiretroviral drugs
* Viral load (VL) \< 50 cp/mL in the past year, with at least 3 VL measurements including screening; only one episode of viral blip \< 200 copies/mL is authorized in the last year
* CD4 T cells \> 250/mm3 at the screening visit
* Estimated glomerular filtration rate \> 60 mL/min (Chronic Kidney Disease - Epidemiology Collaboration method)
* Transaminases : aspartate aminotransférase et alanine aminotransférase \< 3N
* Haemoglobin \> 10 g/dL
* Platelets \> 100 000/mm3
* For women of childbearing age, negative pregnancy test at screening; agree to use mechanical contraception during the study
* Social security system coverage
* Informed consent form signed by patient and investigator

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 98 weeks
* Concomitant treatment using interferon, interleukins, any other immune-therapy or chemotherapy, antivitaminK for patients on ARVT using a 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

Locations (63)

Pointe à Pitre, Guadeloupe, France
Fort-de-France, Martinique, France
Argenteuil, France
Avignon, France
Besançon, France
Bobigny, France
Bondy, France
Bordeaux, France
Bordeaux, France
Boulogne-Billancourt, France
Caen, France
Chartres, France
Clamart, France
Clermont-Ferrand, France
Corbeil-Essonnes, France
Créteil, France
Créteil, France
Dijon, France
Garches, France
Grenoble, France
La Roche-sur-Yon, France
Le Kremlin-Bicêtre, France
Le Mans, France
Levallois-Perret, France
Limoges, France
Lyon, France
Lyon, France
Marseille, France
Marseille, France
Montpellier, France
+ 33 more on CT.gov