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

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. Identifier: NCT00466180
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : October 28, 2010
Information provided by:
University Hospital, Caen

April 25, 2007
April 27, 2007
October 28, 2010
June 2004
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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 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
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Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients
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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.

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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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2006
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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, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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University Hospital, Caen
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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