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

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ClinicalTrials.gov Identifier: NCT00466180
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Nevirapine from twice-a-day to once-a-day Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2004
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. MEMS adherence by electronic devices [ Time Frame: 28-week period (randomized phase) ]

Secondary Outcome Measures :
  1. Virologic efficacy (RNA HIV<400cp/ml)
  2. Immunologic efficacy (CD4 count cells)
  3. Tolerance (hepatic, cutaneous, ANRS safety grade scale)
  4. Pharmacokinetics (nevirapine dosages)

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010

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