Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients (POSOVIR)

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT00466180

First received: April 25, 2007

Last updated: October 27, 2010

Last verified: October 2010

History of Changes

Purpose

Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day.

We hypothesized that once-daily dosing improves adherence.

Condition	Intervention	Phase
HIV Infections	Behavioral: Nevirapine from twice-a-day to once-a-day	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Nevirapine Nevirapine hemihydrate

U.S. FDA Resources

Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:

MEMS adherence by electronic devices [ Time Frame: 28-week period (randomized phase) ]

Secondary Outcome Measures:

Virologic efficacy (RNA HIV<400cp/ml)
Immunologic efficacy (CD4 count cells)
Tolerance (hepatic, cutaneous, ANRS safety grade scale)
Pharmacokinetics (nevirapine dosages)


Enrollment:	62
Study Start Date:	June 2004
Study Completion Date:	November 2006

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months
plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions
accept adherence electronic monitoring
written informed consent signed

Exclusion Criteria:

asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
AST or ALT>1.25N if hepatitis virus B or C were positive

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: NCT00466180

Sponsors and Collaborators

University Hospital, Caen

Investigators


Principal Investigator:	Jean-Jacques Parienti, MD	University Hospital, Caen

More Information

Publications:

Parienti JJ, Massari V, Reliquet V, Chaillot F, Le Moal G, Arvieux C, Vabret A, Verdon R; POSOVIR Study Group. Effect of twice-daily nevirapine on adherence in HIV-1-infected patients: a randomized controlled study. AIDS. 2007 Oct 18;21(16):2217-22.

Parienti JJ, Das-Douglas M, Massari V, Guzman D, Deeks SG, Verdon R, Bangsberg DR. Not all missed doses are the same: sustained NNRTI treatment interruptions predict HIV rebound at low-to-moderate adherence levels. PLoS One. 2008 Jul 30;3(7):e2783. doi: 10.1371/journal.pone.0002783.


ClinicalTrials.gov Identifier:	NCT00466180 History of Changes
Other Study ID Numbers:	POSOVIR
Study First Received:	April 25, 2007
Last Updated:	October 27, 2010
Health Authority:	France: Institutional Ethical Committee

Keywords provided by University Hospital, Caen:


Once-a-day Adherence Nevirapine	Patient noncompliance Administration and dosage Treatment Experienced

Additional relevant MeSH terms:


Nevirapine Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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