QoL and Adherence to One-pill Once-a-day HAART
Phase 3
Completed
- Conditions
- HIV InfectionHIV Infections
- 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
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
- 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