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

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ClinicalTrials.gov Identifier: NCT00990600
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : October 29, 2009
Sponsor:
Information provided by:
A.O. Ospedale Papa Giovanni XXIII

Study Description
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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.


Condition or disease Intervention/treatment Phase
HIV Infection HIV Infections Other: reduced number of pills Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence to a One Pill, Once-a-day Antiretroviral Regimen
Study Start Date : April 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Simplified one pill regimen
Fixed dose combination of tenofovir + emtricitabine + efavirenz
 Other: reduced number of pills
Switch to a fixed dose combination one pill/daily HAART
Other Names:
  • efavirenz EFV
  • emtricitabine FTC
  • tenofovir TDF


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of adherence to HAART [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. QoL (VAS scale) preferences of patients virologic and immunologic outcomes [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990600


Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
Principal Investigator: Franco Maggiolo, MD Ospedali Riuniti, Bergamo
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Franco Maggiolo MD, Divisione di Malattie Infettive, Ospedali Riuniti, Bergamo
ClinicalTrials.gov Identifier: NCT00990600     History of Changes
Other Study ID Numbers: ADONE
EUDRACT NUMBER: 2007-007839-33
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
adherence
Qol
virologic efficacy
immunologic efficacy
 patients' preference
once-daily
HAART
treatment experienced

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Emtricitabine
 Efavirenz
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers