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

NCT ID: NCT02157311

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-01-31

Brief 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 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

Conditions

HIV-1 Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Four consecutive days on treatment and 3 days off

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

Group Type: EXPERIMENTAL

Four consecutive days on treatment and 3 days off

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

tenofovir,; emtricitabine,; abacavir,; lamivudine,; efavirenz,; rilpivirine,; etravirine,; lopinavir/r,; darunavir/r,; atazanavir/r

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian PERRONNE, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Raymond Poincaré

Jean-Claude MELCHIOR, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Raymond Poincaré

Pierre DE TRUCHIS, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Raymond Poincaré

Damien LE DU, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Raymond Poincaré

Locations

Hôpital Meynard

Fort-de-france, Martinique, France

Hôpital Avicenne

Bobigny, , France

CHU Côte de Nacre

Caen, , France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Hôpital Le Bocage

Dijon, , France

Hôpital Raymond Poincaré

Garches, , France

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Hôpital Gui de Chauliac

Montpellier, , France

Hôpital Saint-Antoine

Paris, , France

Hôpital Pitié-Salpêtrière

Paris, , France

Hôpital Européen Georges Pompidou

Paris, , France

Hôpital Necker

Paris, , France

Hôpital Bichat

Paris, , France

Hôpital Tenon

Paris, , France

Hôpital Foch

Suresnes, , France

Hôpital Purpan

Toulouse, , France

Hôpital Bretonneau

Tours, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 29186458 (View on PubMed)

Other Identifiers

2014-000146-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ANRS162-4D

Identifier Type: -

Identifier Source: org_study_id