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

October 6, 2009
October 28, 2009
April 2008
May 2009   (final data collection date for primary outcome measure)
Proportion of adherence to HAART [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00990600 on ClinicalTrials.gov Archive Site
QoL (VAS scale) preferences of patients virologic and immunologic outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
QoL and Adherence to One-pill Once-a-day HAART
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • HIV Infections
Other: reduced number of pills
Switch to a fixed dose combination one pill/daily HAART
Other Names:
  • efavirenz EFV
  • emtricitabine FTC
  • tenofovir TDF
Experimental: Simplified one pill regimen
Fixed dose combination of tenofovir + emtricitabine + efavirenz
Intervention: Other: reduced number of pills
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00990600
ADONE, EUDRACT NUMBER: 2007-007839-33
No
Franco Maggiolo MD, Divisione di Malattie Infettive, Ospedali Riuniti, Bergamo
A.O. Ospedale Papa Giovanni XXIII
Not Provided
Principal Investigator: Franco Maggiolo, MD Ospedali Riuniti, Bergamo
A.O. Ospedale Papa Giovanni XXIII
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP