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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466180
First Posted: April 27, 2007
Last Update Posted: October 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Caen
April 25, 2007
April 27, 2007
October 28, 2010
June 2004
Not Provided
MEMS adherence by electronic devices [ Time Frame: 28-week period (randomized phase) ]
MEMS adherence by electronic devices
Complete list of historical versions of study NCT00466180 on ClinicalTrials.gov Archive Site
  • Virologic efficacy (RNA HIV<400cp/ml)
  • Immunologic efficacy (CD4 count cells)
  • Tolerance (hepatic, cutaneous, ANRS safety grade scale)
  • Pharmacokinetics (nevirapine dosages)
Same as current
Not Provided
Not Provided
 
Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Behavioral: Nevirapine from twice-a-day to once-a-day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
November 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00466180
POSOVIR
No
Not Provided
Not Provided
Not Provided
University Hospital, Caen
Not Provided
Principal Investigator: Jean-Jacques Parienti, MD University Hospital, Caen
University Hospital, Caen
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP