PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

Boehringer Ingelheim280 enrolled

Overview

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.

Study Type

OBSERVATIONAL

Enrollment

280

Conditions

HIV Infections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: The inclusion criteria follow the same criteria which are describe in the newest SPC. Exclusion criteria: The exclusion criteria follow the same criteria which are describe in the newest SPC.

Locations (17)

Boehringer Ingelheim Investigational Site 1

Graz, Austria

Boehringer Ingelheim Investigational Site 2

Linz, Austria

Outcomes

Primary Outcomes

Proportion of Patients Reporting Adverse Events

the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.

Time frame: 48 weeks

Secondary Outcomes

Virologic Response (VR)

VR was defined as Human immunodeficiency virus (HIV) viral load of \<50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) \>= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL \< 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.

Time frame: 48 weeks

Change in CD4+ Cell Count From Baseline to Week 48

Calculated as CD4+ cell count at week 48 minus the baseline value

Time frame: Baseline and week 48

Data from ClinicalTrials.gov

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