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

University Hospital, Caen62 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Nevirapine from twice-a-day to once-a-dayBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

MEMS adherence by electronic devices

Time frame: 28-week period (randomized phase)

Secondary Outcomes

Virologic efficacy (RNA HIV<400cp/ml)

Immunologic efficacy (CD4 count cells)

Tolerance (hepatic, cutaneous, ANRS safety grade scale)

Pharmacokinetics (nevirapine dosages)

Data from ClinicalTrials.gov

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