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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:
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
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   (Adult, Senior)
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:

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:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nevirapine
 Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers

ClinicalTrials.gov processed this record on September 23, 2016