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 successThe 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
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