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

Adherence to a One Pill, Once-a-day Antiretroviral Regimen

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990600

Acronym

ADONE

Enrollment

212

Registered

2009-10-07

Start date

2008-04-30

Completion date

2009-05-31

Last updated

2009-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, HIV Infections

Keywords

adherence, Qol, virologic efficacy, immunologic efficacy, patients' preference, once-daily, HAART, treatment experienced

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.

Interventions

OTHERreduced number of pills

Switch to a fixed dose combination one pill/daily HAART

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of adherence to HAART	6 months

Secondary

Measure	Time frame
QoL (VAS scale) preferences of patients virologic and immunologic outcomes	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026