A Phase 3 interventional study of Four consecutive days on treatment and 3 days off in HIV-1 Infection, sponsored by ANRS, Emerging Infectious Diseases. Completed at 17 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-27.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Treatment
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
ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HIV-1 documented infection
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 :
Exclusion Criteria:
HIV-2 infection
All patients will take a combination of three HIV treatment with a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment
Drug: Four consecutive days on treatment and 3 days off
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
Also known as: tenofovir,, emtricitabine,, abacavir,, lamivudine,, efavirenz,, rilpivirine,, etravirine,, lopinavir/r,, darunavir/r,, atazanavir/r
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
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
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Mutations resistance
The profile of new resistance mutations in case of virological failure
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Evaluation CD4, CD8 and CD4/CD8 ratios
Measurement of the CD4 cell count, CD8 cell count, and CD4/CD8 ratio
Time frame: Week 0, week 8, week 16, week 24, week 24, week 32, week 40 and week 48
HIV proviral DNA
The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC)
Time frame: Week 0, Week 24 and Week 48
Clinical events related to HIV infection
Clinical events related to HIV infection, according to the US CDC classification
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Adverse events
Collect all clinical and biological adverse events
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Interruption or modification of the therapeutic strategy
Every interruption or modification of the therapeutic strategy for more than 30 days
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Renal parameters
The evolution of creatinin and clearance of creatinin between week 0 and Week 48.
Time frame: Week 0, week 8, week 16, week 24, week 32, week 40 and week 48
Inflammation and immune activation
The evolution of inflammation and immune activation parameters (IL-6, CRP-US, CD14s, IP-10 and MIG-1). The measurement will be done at the end of the study in a central lab on the biobank
Time frame: Week 0, week 24 and Week 48
Antiretrovirals Pharmacokinetic
The evolution of pharmacokinetic parameters, for protease inhibitors (lopinavir, darunavir or atazanavir) or non-nucleoside reverse transcriptase inhibitors (efavirensz, etravirine or rilpivirine) The measurment will be done on the sample bank at the end of the study in a central lab
Time frame: Week 0, week 24 and week 48
Antiretrovirals pharmacokinetic
Measurment of Residual plasmatic concentrations of protease inhibitors (lopinavir/r - darunavir/r - atazanavir/r ) or non-nucleoside reverse transcriptase inhibitors (efavirenz or rilpivirine or etravirine), at the end of the 3-days off, from Day 0 to week 48. The measurment will be done on the sample bank at the end of the study in a central lab
Time frame: week 4, week8, week 12, week 24, week 32 and week 48
Quality of life
selfquestionnary to measure the quality of life (PRO-QOL HIV and felt symptoms )
Time frame: week 0, week 24 and week 48
Adherence
Measurement of treatment adherence (questionnaire, self-survey book, pharmacological measures of antiretroviral drugs, medication event monitoring system)
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Hepatitis parameters
Measurment of AST, SGOT, CGT
Time frame: Week 0, week 8, week 16, week 24, week 32, week 40 and week 48
Glucidolipidics parameters
Measurement of Glycemia, Triglycerids, total cholesterol, HDL and LDL
Time frame: Week 0, week 24 and week 48
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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ANRS, Emerging Infectious Diseases