4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV Patients

ANRS, Emerging Infectious Diseases100 enrolled

Overview

Evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads \> 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days).

Methods: Open-label, multicentric, prospective, non-randomized, non-controlled trial to evaluate at 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads \> 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days). Allocation: Non-randomized Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment Enrollment: 100 patients

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

HIV-1 Infection

Interventions

Four consecutive days on treatment and 3 days offDRUG

All patients will take a combination of three of these treatment with a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * • HIV-1 documented infection * Age 18 years or older * HIV-1 viral load always ≤ 50 cp/mL for at least 12 months (with a minimum of 3 measures in the last 12 months, including screening) * CD4+ lymphocytes count \> 250/mm3, for at least 6 months * Treatment with a stable regimen for at least 4 months prior to screening, containing 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTI) combined with, either 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 ritonavir-boosted protease inhibitor (PI/r). The list of accepted antiretroviral drugs is limited to : 1. NRTI : tenofovir, emtricitabine, abacavir, lamivudine 2. PI/r : lopinavir/r, darunavir/r or atazanavir/r 3. NNRTI : efavirenz, rilpivirine or etravirine. * Exclusive antiretroviral 3 drug-therapy (no 4 drug-therapy) * A least one genotypic resistance test available (reverse transcriptase and/or protease amino acid sequence, according to on-going antiretroviral drugs) ; on each genotypic resistance test(s) available in medical history, susceptibility to every on-going antiretroviral drugs must be demonstrated * Clearance of the creatinine \> 60 mL/min (MDRD) * ASAT and ALAT \< 3 ULN * Hemoglobin \> 10 g/dl * Platelets count \> 100 000/mm3 * Negative pregnancy test for potential child-bearing women and mechanical contraception for sexual intercourses * Patient living in France and affiliated to a social security system * Written informed consent Exclusion Criteria: * • HIV-2 infection * HBV infection (positive HBs antigen) or isolated positive HBc antibody * HCV infection requiring specific treatment during the 51 weeks of the trial * At least one known resistance to one of on-going antiretroviral drugs * Exclusive antiretroviral 3 drug-therapy (no 4 drug-therapy) * No genotypic resistance test available * On-going either interferon, interleukin treatment, or every immuno- / chemo-therapy * Progressive opportunistic infection, on-going treatment for opportunistic infection or tuberculosis * Patient with irregular follow-up or with treatment adherence problems * Any condition (alcohol, drug abuse…) compromising treatment adherence, treatment safety, and/or study adherence * Progressive neurological disorders (meningitis, encephalitis, myelitis…) related to HIV infection or not * Medical history of severe neuropsychiatric disorder, with insufficient treatment efficacy * Subject under legal guardianship or incapacitation

Locations (17)

Hôpital Meynard

Fort-de-france, Martinique, France

Hôpital Avicenne

Bobigny, France

CHU Côte de Nacre

Caen, France

Outcomes

Primary Outcomes

Capacity to maintain a therapeutic success with 4 days on treatment followed 3 days off treatment

To evaluate after 48 weeks, the capacity of a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment, in HIV-1 treated patients with undetectable viral load for at least 12 months and continuous antiretroviral regimen unchanged for at least 4 months, to maintain a therapeutic success defined by the absence of virological failure (2 consecutive viral loads \> 50 cp/mL) and the absence of interruption of therapeutic strategy (interruption or change of the " 4 days on / 3 days off " strategy for a time longer than 30 consecutive days).

Time frame: Week 48

Secondary Outcomes

Virological success

The HIV-1 viral load at week 48 must be inferior to 50 copies/mL

Time frame: Week 48

The time of virological failure occurrence

Measure the delay between week 0 and the date of the different virologic failure

Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51

The blips

Number of blips (viral load detectable on 1 sample) during the study

Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51

The low viral loads (between 20 - 50 cp/mL)

Measurement of the low viral loads (between 20 - 50 cop/mL)

Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51

Detected signal on viral quantification

The presence or not of detected signal when no quantification is possible on viral loads

Data from ClinicalTrials.gov

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