HIV-1 InfectionPhase 3ANRS162-4DNCT02157311
4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV Patients
A Phase 3 study testing Four consecutive days on treatment and 3 days off in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 17 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Four consecutive days on treatment and 3 days off
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 17 sitesFrance
- Study dates
- Jul 2014to Jan 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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 :
- NRTI : tenofovir, emtricitabine, abacavir, lamivudine
Show all 17Show fewer
- PI/r : lopinavir/r, darunavir/r or atazanavir/r
- 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
Who cannot join
- • 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
Show all 13Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Hôpital Avicenne
Bobigny, 93000
CHU Côte de Nacre
Caen, 14033
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
Hôpital Le Bocage
Dijon, 21079
Hôpital Meynard
Fort-de-france, Martinique, 97261
Hôpital Raymond Poincaré
Garches, 92380
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Hôpital Gui de Chauliac
Montpellier, 34295
Hôpital Saint-Antoine
Paris, 75012
Hôpital Pitié-Salpêtrière
Paris, 75013
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Necker
Paris, 75015
Hôpital Bichat
Paris, 75018
Hôpital Tenon
Paris, 75020
Hôpital Foch
Suresnes, 92151
Hôpital Purpan
Toulouse, 31059
Hôpital Bretonneau
Tours, 37044
About this study
Official title: Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent Maintenance Therapy After a Successful Continuous Induction Therapy.
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).
Read the detailed description
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
- Conditions
- HIV-1 Infection
- Being tested
- Four consecutive days on treatment and 3 days off
- Keywords
- HIV-1, simplification,, treatment discontinuation, virological success, four days a week
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four consecutive days on treatment and 3 days offDrug
Also called tenofovir,, emtricitabine,, abacavir,, lamivudine,
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
| Study group | Role | What they receive |
|---|---|---|
| Four consecutive days on treatment and 3 days off | Experimental | 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 Receives: Drug: Four consecutive days on treatment and 3 days off |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 48
Secondary outcomes (19)
Virological success
The HIV-1 viral load at week 48 must be inferior to 50 copies/mL
Measured: Week 48
The time of virological failure occurrence
Measure the delay between week 0 and the date of the different virologic failure
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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 )
Measured: 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)
Measured: 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
Measured: 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
Measured: Week 0, week 24 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Christian PERRONNE, MD-PHD, Principal investigator, Hôpital Raymond PoincaréJean-Claude MELCHIOR, MD-PHD, Principal investigator, Hôpital Raymond PoincaréPierre DE TRUCHIS, MD, Principal investigator, Hôpital Raymond PoincaréDamien LE DU, MD, Principal investigator, Hôpital Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157311
- Sponsor's protocol ID
- ANRS162-4D
- Other IDs
- 2014-000146-29, 2014
- Acronym
- ANRS162-4D
- Status last verified
- Jan 2016
- First submitted
- 21 May 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Truchis P, Assoumou L, Landman R, Mathez D, Le Du D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.
PubMed 29186458
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent Maintenance Therapy After a Successful Continuous Induction Therapy.
- ClinicalTrials.gov ID
- NCT02157311
- Acronym / sponsor ID
- ANRS162-4D / ANRS162-4D
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1, simplification,, treatment discontinuation, virological success, four days a week
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Four consecutive days on treatment and 3 days off | Experimental | Drug: Four consecutive days on treatment and 3 days offAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- • HIV-1 documented infection
Key exclusion criteria (13 listed)
- • HIV-2 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Four consecutive days on treatment and 3 days offAlso: tenofovir,, emtricitabine,, abacavir,, lamivudine,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 | Drug | Four consecutive days on treatment and 3 days off |
Primary outcome
Capacity to maintain a therapeutic success with 4 days on treatment followed 3 days off treatment
Time frame: Week 48
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).
19 secondary outcomes
Virological success
Time frame: Week 48
The time of virological failure occurrence
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
The blips
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)
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
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Mutations resistance
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
Time frame: Week 0, week 8, week 16, week 24, week 24, week 32, week 40 and week 48
HIV proviral DNA
Time frame: Week 0, Week 24 and Week 48
Clinical events related to HIV infection
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
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
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Renal parameters
Time frame: Week 0, week 8, week 16, week 24, week 32, week 40 and week 48
Inflammation and immune activation
Time frame: Week 0, week 24 and Week 48
Antiretrovirals Pharmacokinetic
Time frame: Week 0, week 24 and week 48
Antiretrovirals pharmacokinetic
Time frame: week 4, week8, week 12, week 24, week 32 and week 48
Quality of life
Time frame: week 0, week 24 and week 48
Adherence
Time frame: Week 0, Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 51
Hepatitis parameters
Time frame: Week 0, week 8, week 16, week 24, week 32, week 40 and week 48
Glucidolipidics parameters
Time frame: Week 0, week 24 and week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 29186458de Truchis P, Assoumou L, Landman R, Mathez D, Le Du D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian PERRONNE, MD-PHD principal investigator
Hôpital Raymond Poincaré
Jean-Claude MELCHIOR, MD-PHD principal investigator
Hôpital Raymond Poincaré
Pierre DE TRUCHIS, MD principal investigator
Hôpital Raymond Poincaré
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Four consecutive days on treatment and 3 days off in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capacity to maintain a therapeutic success with 4 days on treatment followed 3 days off treatment (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.