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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:
University Hospital, Caen
Information provided by:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT00466180
First received: April 25, 2007
Last updated: October 27, 2010
Last verified: October 2010
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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 Intervention Model: Parallel Assignment Masking: None (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 |
Eligibility| 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
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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
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 |
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 19, 2017