Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients (POSOVIR)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nevirapine from twice-a-day to once-a-day
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Once-a-day, Adherence, Nevirapine, Patient noncompliance, Administration and dosage, Treatment Experienced
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
MEMS adherence by electronic devices
Secondary Outcome Measures
Virologic efficacy (RNA HIV<400cp/ml)
Immunologic efficacy (CD4 count cells)
Tolerance (hepatic, cutaneous, ANRS safety grade scale)
Pharmacokinetics (nevirapine dosages)
Full Information
NCT ID
NCT00466180
First Posted
April 25, 2007
Last Updated
October 27, 2010
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT00466180
Brief Title
Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
Acronym
POSOVIR
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Once-a-day, Adherence, Nevirapine, Patient noncompliance, Administration and dosage, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Nevirapine from twice-a-day to once-a-day
Primary Outcome Measure Information:
Title
MEMS adherence by electronic devices
Time Frame
28-week period (randomized phase)
Secondary Outcome Measure Information:
Title
Virologic efficacy (RNA HIV<400cp/ml)
Title
Immunologic efficacy (CD4 count cells)
Title
Tolerance (hepatic, cutaneous, ANRS safety grade scale)
Title
Pharmacokinetics (nevirapine dosages)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Parienti, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18665246
Citation
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.
Results Reference
background
PubMed Identifier
18090049
Citation
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. doi: 10.1097/QAD.0b013e3282eff388.
Results Reference
result
Learn more about this trial
Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
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