Status:
UNKNOWN
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
IMEA Leon M'Ba Foundation
INSERM UMR S 1136
Conditions:
HIV Infections
Eligibility:
All Genders
18+ 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 treatment taken 4 consecutive days a week versus c...
Detailed Description
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 therap...
Eligibility Criteria
Inclusion
- 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).
- If a genotype is available in the patient medical history; viruses must be susceptible to all ongoing antiretroviral drugs
- 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
- 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
Key Trial Info
Start Date :
September 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT03256422
Start Date
September 7 2017
End Date
December 1 2020
Last Update
February 5 2018
Active Locations (63)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Pointe-à-Pitre
Pointe à Pitre, Guadeloupe, France, 97159
2
Hôpital La Meynard Zobda Quitman
Fort-de-France, Martinique, France, 97261
3
Centre hospitalier Victor Dupouy
Argenteuil, France, 95100
4
Hôpital Henri Duffaut
Avignon, France, 84000