Antiretroviral regimen 4 days a week.

Randomized, open-label and multicentric trial evaluating the non-inferiority of antiretroviral treatment taken 4 consecutive days per week versus continuous therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral therapy - QUATUOR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000040-17-FR

Enrollment

640

Registered

2017-07-24

Start date

2017-07-02

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection MedDRA version: 20.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: VIREAD Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATE CAS Number: 202138-50-9 Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion 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 2INTIs+PI or 2INTIs+INNTI or 2INTIs+INI. 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 ARN 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) 250/mm3 at the screening visit • Estimated glomerular filtration rate > 60 mL/min (CKD-EPI method) • AST et ALT 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 620 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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. • 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the non-inferiority at 48 weeks of treatment 4 consecutive days per week vs ongoing treatment 7 days per week in patient controlled with antiretroviral therapy (Viral load 50 cp/mL at 2 to 4 weeks apart) and no discontinuation or modification of the study strategy for more than 30 consecutive days ;Timepoint(s) of evaluation of this end point: Week 48	—

Secondary

Measure	Time frame
Secondary end point(s): • Proportion of patients with therapeutic success until W96 • Proportion of patients on virological success at W48 and W96 • Median time to virological failure • Proportion of patients with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by NGS • Frequency of minority resistant variants archived in DNA at W0 and their impact on virological failure (2 consecutive VL> 50 copies / mL) and on the acquisition of drugs resistance mutations • Percentage of patients with at least one episode of "blip" (viral load >50 copies/mL followed by a control value = 50 cp/mL) between W0 and W48, and between W0 and W96 • Percentage of patients with a viral load signal detected between W0 and W48 and W0 and W96 (subgroup of patients tested with Roche-Taqman, threshold50 cp/mL). • Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE) • Evolution of T CD4 and CD8 cells count, and CD4/CD8 ratio from W-4 to W48 and W96 • Evolution of fasting metabolic parameters (total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia) until W48 and W96 • Evolution of inflammation serum parameters (sCD14, sCD163, IP-10, CRPus, IL-6, D-dimers, sTNFR1, sTNFR2) from W0 to W24 and W48 (120 patients) • Evolution of semen viral load at W0, W24 and W48 (120 patients). • Description of plasmatic concentrations of third antiretroviral agents (INI, PI, INNTI) at W0, W4, W12, W24, W36, W48, W60, W72, W84 and W96 • Description of plasmatic concentrations of tenofovir (TDF or TAF) at W0, W4, W12, W24, W36, W48, W60, W72, W84 and W96 • Description of intracellular drug concentrations (substudy in 120 patients)at W0, W24, and W48 • Evaluation of the medico economic costs in the 2 groups of patients • Evolution of the quality of life by self-reported questionnaire at W-4, W0, W12, W48 and W96 • Evaluation of the adherence by self-reported ques	—

Measure

Time frame

Secondary end point(s): • Proportion of patients with therapeutic success until W96 • Proportion of patients on virological success at W48 and W96 • Median time to virological failure • Proportion of patients with acquisition of drugs resistance mutations in case of virological failure detected by Sanger and by NGS • Frequency of minority resistant variants archived in DNA at W0 and their impact on virological failure (2 consecutive VL> 50 copies / mL) and on the acquisition of drugs resistance mutations • Percentage of patients with at least one episode of "blip" (viral load >50 copies/mL followed by a control value = 50 cp/mL) between W0 and W48, and between W0 and W96 • Percentage of patients with a viral load signal detected between W0 and W48 and W0 and W96 (subgroup of patients tested with Roche-Taqman, threshold50 cp/mL). • Frequency of grade 3 or more adverse events, adverse effects, drug-modifying adverse events, drug-related adverse events and serious adverse events (SAE) • Evolution of T CD4 and CD8 cells count, and CD4/CD8 ratio from W-4 to W48 and W96 • Evolution of fasting metabolic parameters (total cholesterol total, LDL-C, HDL-C, Triglycerides and glycemia) until W48 and W96 • Evolution of inflammation serum parameters (sCD14, sCD163, IP-10, CRPus, IL-6, D-dimers, sTNFR1, sTNFR2) from W0 to W24 and W48 (120 patients) • Evolution of semen viral load at W0, W24 and W48 (120 patients). • Description of plasmatic concentrations of third antiretroviral agents (INI, PI, INNTI) at W0, W4, W12, W24, W36, W48, W60, W72, W84 and W96 • Description of plasmatic concentrations of tenofovir (TDF or TAF) at W0, W4, W12, W24, W36, W48, W60, W72, W84 and W96 • Description of intracellular drug concentrations (substudy in 120 patients)at W0, W24, and W48 • Evaluation of the medico economic costs in the 2 groups of patients • Evolution of the quality of life by self-reported questionnaire at W-4, W0, W12, W48 and W96 • Evaluation of the adherence by self-reported ques

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Countries

France

Contacts

Public ContactJuliette SAILLARD

ANRS

juliette.saillard@anrs.fr33153946039

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026