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QoL and Adherence to One-pill Once-a-day HAART (ADONE)

Primary Purpose

HIV Infection, HIV Infections

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
reduced number of pills
Sponsored by
A.O. Ospedale Papa Giovanni XXIII
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring adherence, Qol, virologic efficacy, immunologic efficacy, patients' preference, once-daily, HAART, treatment experienced

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years
  • Informed consent signed
  • Effective ongoing treatment (HIV-RNA < 50 copies/ml) for at least three months

  • Being on a stable HAART regimen based either on two possible drug associations:

    • 3TC/FTC + TDF + EFV
    • FTC/TDF (fixed dose combination) + EFV
  • No previous documented virologic failure

Exclusion Criteria:

  • Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
  • Any ongoing grade 4 laboratory abnormality

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Simplified one pill regimen

    Arm Description

    Fixed dose combination of tenofovir + emtricitabine + efavirenz

    Outcomes

    Primary Outcome Measures

    Proportion of adherence to HAART

    Secondary Outcome Measures

    QoL (VAS scale) preferences of patients virologic and immunologic outcomes

    Full Information

    First Posted
    October 6, 2009
    Last Updated
    October 28, 2009
    Sponsor
    A.O. Ospedale Papa Giovanni XXIII
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00990600
    Brief Title
    QoL and Adherence to One-pill Once-a-day HAART
    Acronym
    ADONE
    Official Title
    Adherence to a One Pill, Once-a-day Antiretroviral Regimen
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    A.O. Ospedale Papa Giovanni XXIII

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Primary objective of the study is: To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infection, HIV Infections
    Keywords
    adherence, Qol, virologic efficacy, immunologic efficacy, patients' preference, once-daily, HAART, treatment experienced

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    212 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Simplified one pill regimen
    Arm Type
    Experimental
    Arm Description
    Fixed dose combination of tenofovir + emtricitabine + efavirenz
    Intervention Type
    Other
    Intervention Name(s)
    reduced number of pills
    Other Intervention Name(s)
    efavirenz EFV, emtricitabine FTC, tenofovir TDF
    Intervention Description
    Switch to a fixed dose combination one pill/daily HAART
    Primary Outcome Measure Information:
    Title
    Proportion of adherence to HAART
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    QoL (VAS scale) preferences of patients virologic and immunologic outcomes
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years Informed consent signed Effective ongoing treatment (HIV-RNA < 50 copies/ml) for at least three months Being on a stable HAART regimen based either on two possible drug associations: 3TC/FTC + TDF + EFV FTC/TDF (fixed dose combination) + EFV No previous documented virologic failure Exclusion Criteria: Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours Any ongoing grade 4 laboratory abnormality
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Franco Maggiolo, MD
    Organizational Affiliation
    Ospedali Riuniti, Bergamo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    QoL and Adherence to One-pill Once-a-day HAART

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