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

Information source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: Four consecutive days on treatment and 3 days off (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Official(s) and/or principal investigator(s):
Christian PERRONNE, MD-PHD, Principal Investigator, Affiliation: Hôpital Raymond Poincaré
Jean-Claude MELCHIOR, MD-PHD, Principal Investigator, Affiliation: Hôpital Raymond Poincaré
Pierre DE TRUCHIS, MD, Principal Investigator, Affiliation: Hôpital Raymond Poincaré
Damien LE DU, MD, Principal Investigator, Affiliation: Hôpital Raymond Poincaré

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).

Clinical Details

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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Virological success

The time of virological failure occurrence

The blips

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

Detected signal on viral quantification

Mutations resistance

Evaluation CD4, CD8 and CD4/CD8 ratios

HIV proviral DNA

Clinical events related to HIV infection

Adverse events

Interruption or modification of the therapeutic strategy

Renal parameters

Inflammation and immune activation

Antiretrovirals Pharmacokinetic

Antiretrovirals pharmacokinetic

Quality of life

Adherence

Hepatitis parameters

Glucidolipidics parameters

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hôpital Avicenne, Bobigny 93000, France

CHU Côte de Nacre, Caen 14033, France

Centre Hospitalier Sud Francilien, Corbeil Essonnes 91100, France

Hôpital Le Bocage, Dijon 21079, France

Hôpital Raymond Poincaré, Garches 92380, France

Hôpital Bicêtre, Kremlin Bicetre 94275, France

Hôpital Gui de Chauliac, Montpellier 34295, France

Hôpital Bichat, Paris 75018, France

Hôpital Européen Georges Pompidou, Paris 75015, France

Hôpital Necker, Paris 75015, France

Hôpital Pitié-Salpêtrière, Paris 75013, France

Hôpital Saint-Antoine, Paris 75012, France

Hôpital Tenon, Paris 75020, France

Hôpital Foch, Suresnes 92151, France

Hôpital Purpan, Toulouse 31059, France

Hôpital Bretonneau, Tours 37044, France

Hôpital Meynard, Fort-de-france, Martinique 97261, France

Additional Information

Starting date: July 2014
Last updated: October 28, 2014

Page last updated: August 23, 2015

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