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

Adherence to a One Pill, Once-a-day Antiretroviral Regimen

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV Infection
• Intervention / Treatment: Other: reduced number of pills

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of adherence to HAART	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
QoL (VAS scale) preferences of patients virologic and immunologic outcomes	6 months

Collaborators and Investigators

• Sponsor: A.O. Ospedale Papa Giovanni XXIII
• Investigators: Principal Investigator: Franco Maggiolo, MD, Ospedali Riuniti, Bergamo

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: October 6, 2009
• First Submitted That Met QC Criteria: October 6, 2009
• First Posted (Estimate): October 7, 2009

Study Record Updates

• Last Update Posted (Estimate): October 29, 2009
• Last Update Submitted That Met QC Criteria: October 28, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: adherence; treatment experienced; HAART; once-daily; Qol; virologic efficacy; immunologic efficacy; patients' preference
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Tenofovir; Emtricitabine; Efavirenz
• Other Study ID Numbers: ADONE; EUDRACT NUMBER: 2007-007839-33