Trial record 16 of 18 for:    " April 11, 2007":" May 11, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Information provided by:
University Hospital, Caen Identifier:
First received: April 25, 2007
Last updated: October 27, 2010
Last verified: October 2010

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:

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

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

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
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Please refer to this study by its identifier: NCT00466180

Sponsors and Collaborators
University Hospital, Caen
Principal Investigator: Jean-Jacques Parienti, MD University Hospital, Caen
  More Information

Publications: 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:
Patient noncompliance
Administration and dosage
Treatment Experienced

Additional relevant MeSH terms:
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 processed this record on November 27, 2015