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. |
ClinicalTrials.gov Identifier: NCT00466180 |
Recruitment Status
:
Completed
First Posted
: April 27, 2007
Last Update Posted
: October 28, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
Actual Study Completion Date : | November 2006 |

- MEMS adherence by electronic devices [ Time Frame: 28-week period (randomized phase) ]
- Virologic efficacy (RNA HIV<400cp/ml)
- Immunologic efficacy (CD4 count cells)
- Tolerance (hepatic, cutaneous, ANRS safety grade scale)
- Pharmacokinetics (nevirapine dosages)

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
Principal Investigator: | Jean-Jacques Parienti, MD | University Hospital, Caen |
Publications of Results:
Other 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 |