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

Phase 3

Completed

• Conditions: HIV Infection; HIV Infections
• Interventions: Other: reduced number of pills

• Registration Number: NCT00990600
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-10
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Last Update Submitted: 2009-10-28
• Last Update Posted: 2009-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simplified one pill regimen	reduced number of pills	Fixed dose combination of tenofovir + emtricitabine + efavirenz

Primary Outcome Measures

Name	Time	Method
Proportion of adherence to HAART	6 months

Secondary Outcome Measures

Name	Time	Method
QoL (VAS scale) preferences of patients virologic and immunologic outcomes	6 months