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

A.O. Ospedale Papa Giovanni XXIII212 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

212

Conditions

HIV Infection HIV Infections

Interventions

reduced number of pillsOTHER

Switch to a fixed dose combination one pill/daily HAART

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of adherence to HAART

Time frame: 6 months

Secondary Outcomes

QoL (VAS scale) preferences of patients virologic and immunologic outcomes

Time frame: 6 months

Data from ClinicalTrials.gov

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