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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reduced number of pills

Other

Switch to a fixed dose combination one pill/daily HAART

Other names: efavirenz EFV, emtricitabine FTC, tenofovir TDF

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

Sponsors and collaborators

Lead sponsor

A.O. Ospedale Papa Giovanni XXIII

Other

Registry information

Official study title

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

Acronym: ADONE

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 7, 2009
Registry last updated: Oct 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed