Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice

Boehringer Ingelheim

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT01524900

1100.1550

Details and patient eligibility

About

This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and pre-treated patients switching from nevirapine immediate release or other anti-retroviral therapy (ART) will be included in the study. The decision to initiate treatment with nevirapine extended release is independent of this study and is based entirely on individual patient need and the judgement of the treating physician. The aim of the study is to assess the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1 infected patients in routine clinical practice. It is planned to document five visits for each patient over a twenty four week observational period.

Full description

Study Design:

non-interventional uncontrolled observational study

Enrollment: 398 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HIV-1 infected male and female 18 years and above;
2. anti-retroviral therapy (ART) naive and pre-treated patients switching from a nevirapine immediate release or other ART.

Exclusion criteria

Consistent with the current VIRAMUNE prolonged release SPC.

Trial design

398 participants in 1 patient group

nevirapine extended release