patient HIV MedDRA version: 9.1 Level: HLT Classification code 10038997 Term: Retroviral infections
Conditions
Interventions
Trade Name: ATRIPLA
Pharmaceutical Form: Tablet
INN or Proposed INN: efavirenz
Concentration type: equal
INN or Proposed INN: emtricitabine
Concentration type: equal
INN or Proposed INN: tenofovir dis
Sponsors
AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years Informed consent signed Effective ongoing treatment (HIV-RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours ii. Any ongoing grade 4 laboratory abnormality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify if simplification of the antiretroviral regimen, measured as the reduction of pill burden alone, may affect adherence rate of patients.;Secondary Objective:  To verify the effect of the simplification strategy on quality of life (QoL)  To verify preferences of patients  To establish virologic and immunologic outcomes of the simplified regimen;Primary end point(s): The primary end-point aims to evaluate if adherence may be improved just by reducing the daily pill burden without changing the current HAART regimen and to quantify this change. Sample size has been defined on this end-point. The secondary end-points will have an exploratory meaning. | — |
Countries
Italy
Outcome results
None listed