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

October 27, 2010 updated by: University Hospital, Caen

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.

Study Overview

Status

Completed

Conditions

HIV Infections

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MEMS adherence by electronic devices Time Frame: 28-week period (randomized phase)	28-week period (randomized phase)

Secondary Outcome Measures

Outcome Measure
Virologic efficacy (RNA HIV<400cp/ml)
Immunologic efficacy (CD4 count cells)
Tolerance (hepatic, cutaneous, ANRS safety grade scale)
Pharmacokinetics (nevirapine dosages)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria