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NCT00466180 Clinical Trial

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

HIV Infections Clinical Trial

— POSOVIR  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00466180
Other study ID # POSOVIR
Secondary ID
Status Completed
Phase Phase 4
First received April 25, 2007
Last updated October 27, 2010
Start date June 2004
Est. completion date November 2006

Study information
Verified date October 2010
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority France: Institutional Ethical Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Nevirapine from twice-a-day to once-a-day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

References & Publications (2)

Parienti JJ, Das-Douglas M, Massari V, Guzman D, Deeks SG, Verdon R, Bangsberg DR. Not all missed doses are the same: sustained NNRTI treatment interruptions predict HIV rebound at low-to-moderate adherence levels. PLoS One. 2008 Jul 30;3(7):e2783. doi: 10.1371/journal.pone.0002783. — View Citation

Parienti JJ, Massari V, Reliquet V, Chaillot F, Le Moal G, Arvieux C, Vabret A, Verdon R; POSOVIR Study Group. Effect of twice-daily nevirapine on adherence in HIV-1-infected patients: a randomized controlled study. AIDS. 2007 Oct 18;21(16):2217-22. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary MEMS adherence by electronic devices 28-week period (randomized phase)
Secondary Virologic efficacy (RNA HIV<400cp/ml)
Secondary Immunologic efficacy (CD4 count cells)
Secondary Tolerance (hepatic, cutaneous, ANRS safety grade scale)
Secondary Pharmacokinetics (nevirapine dosages)
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