Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier:
NCT00990600
First received: October 6, 2009
Last updated: October 28, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
HIV Infection
HIV Infections
Other: reduced number of pills
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adherence to a One Pill, Once-a-day Antiretroviral Regimen

Resource links provided by NLM:


Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:
  • Proportion of adherence to HAART [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QoL (VAS scale) preferences of patients virologic and immunologic outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990600

Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
Principal Investigator: Franco Maggiolo, MD Ospedali Riuniti, Bergamo
  More Information

No publications provided

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
Study First Received: October 6, 2009
Last Updated: October 28, 2009
Health Authority: Italy: Istituto Superiore di Sanità (ISS)

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Communicable Diseases
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Contraceptives, Oral
Emtricitabine
Anti-Infective Agents
Antiviral Agents
Contraceptive Agents
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014