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Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients (POSOVIR)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nevirapine from twice-a-day to once-a-day
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Once-a-day, Adherence, Nevirapine, Patient noncompliance, Administration and dosage, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months
  • plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions
  • accept adherence electronic monitoring
  • written informed consent signed

Exclusion Criteria:

  • asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
  • AST or ALT>1.25N if hepatitis virus B or C were positive

Sites / Locations

    Outcomes

    Primary Outcome Measures

    MEMS adherence by electronic devices

    Secondary Outcome Measures

    Virologic efficacy (RNA HIV<400cp/ml)
    Immunologic efficacy (CD4 count cells)
    Tolerance (hepatic, cutaneous, ANRS safety grade scale)
    Pharmacokinetics (nevirapine dosages)

    Full Information

    First Posted
    April 25, 2007
    Last Updated
    October 27, 2010
    Sponsor
    University Hospital, Caen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00466180
    Brief Title
    Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
    Acronym
    POSOVIR
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Caen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day. We hypothesized that once-daily dosing improves adherence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    Once-a-day, Adherence, Nevirapine, Patient noncompliance, Administration and dosage, Treatment Experienced

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Nevirapine from twice-a-day to once-a-day
    Primary Outcome Measure Information:
    Title
    MEMS adherence by electronic devices
    Time Frame
    28-week period (randomized phase)
    Secondary Outcome Measure Information:
    Title
    Virologic efficacy (RNA HIV<400cp/ml)
    Title
    Immunologic efficacy (CD4 count cells)
    Title
    Tolerance (hepatic, cutaneous, ANRS safety grade scale)
    Title
    Pharmacokinetics (nevirapine dosages)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions accept adherence electronic monitoring written informed consent signed Exclusion Criteria: asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative AST or ALT>1.25N if hepatitis virus B or C were positive
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean-Jacques Parienti, MD
    Organizational Affiliation
    University Hospital, Caen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18665246
    Citation
    Parienti JJ, Das-Douglas M, Massari V, Guzman D, Deeks SG, Verdon R, Bangsberg DR. Not all missed doses are the same: sustained NNRTI treatment interruptions predict HIV rebound at low-to-moderate adherence levels. PLoS One. 2008 Jul 30;3(7):e2783. doi: 10.1371/journal.pone.0002783.
    Results Reference
    background
    PubMed Identifier
    18090049
    Citation
    Parienti JJ, Massari V, Reliquet V, Chaillot F, Le Moal G, Arvieux C, Vabret A, Verdon R; POSOVIR Study Group. Effect of twice-daily nevirapine on adherence in HIV-1-infected patients: a randomized controlled study. AIDS. 2007 Oct 18;21(16):2217-22. doi: 10.1097/QAD.0b013e3282eff388.
    Results Reference
    result

    Learn more about this trial

    Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients

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