QoL and Adherence to One-pill Once-a-day HAART (ADONE)

This study has been completed.

Sponsor:

Information provided by:

A.O. Ospedale Papa Giovanni XXIII

ClinicalTrials.gov Identifier:

NCT00990600

First received: October 6, 2009

Last updated: October 28, 2009

Last verified: October 2009

History of Changes

Purpose

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.

Condition	Intervention	Phase
HIV Infection HIV Infections	Other: reduced number of pills	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Adherence to a One Pill, Once-a-day Antiretroviral Regimen

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Efavirenz

U.S. FDA Resources

Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:

Proportion of adherence to HAART [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

QoL (VAS scale) preferences of patients virologic and immunologic outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Enrollment:	212
Study Start Date:	April 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Simplified one pill regimen Fixed dose combination of tenofovir + emtricitabine + efavirenz	Other: reduced number of pills Switch to a fixed dose combination one pill/daily HAART Other Names: efavirenz EFV emtricitabine FTC tenofovir TDF

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990600

Sponsors and Collaborators

A.O. Ospedale Papa Giovanni XXIII

Investigators


Principal Investigator:	Franco Maggiolo, MD	Ospedali Riuniti, Bergamo

More Information

No publications provided


Responsible Party:	Franco Maggiolo MD, Divisione di Malattie Infettive, Ospedali Riuniti, Bergamo
ClinicalTrials.gov Identifier:	NCT00990600 History of Changes
Other Study ID Numbers:	ADONE, EUDRACT NUMBER: 2007-007839-33
Study First Received:	October 6, 2009
Last Updated:	October 28, 2009
Health Authority:	Italy: Istituto Superiore di Sanità (ISS)

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:


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

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome Communicable Diseases HIV Infections Infection Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases	Virus Diseases Contraceptives, Oral Emtricitabine Anti-Infective Agents Antiviral Agents Contraceptive Agents Contraceptive Agents, Female Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015

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