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

NCT01524900 | Completed Results

• 1 other identifier: 1100.1550
• Study Type: observational
• Target: 398
• Locations: 3 countries
• Sites: 53

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

• Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation

  The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.

  up to 72 weeks

• Number of Patients Reporting Rash of Any Severity

  Number of patients reporting rash of any severity as adverse event

  up to 72 weeks

• Number of Patients Reporting Hepatic Events

  Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.

  up to 72 weeks

Secondary Outcomes (4)

• Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)

  24 weeks

• Change in CD4+ Cell Count From Baseline to Week 24

  baseline and week 24

• Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks

  baseline and week 24

• Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation

  24 weeks

Study Arms (1)

nevirapine extended release

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

HIV-1 infected patients

You may qualify if:

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

You may not qualify if:

• Consistent with the current VIRAMUNE prolonged release SPC.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (53)

Boehringer Ingelheim Investigational Site 6

Graz, Austria

Location

Boehringer Ingelheim Investigational Site 5

Salzburg, Austria

Location

Boehringer Ingelheim Investigational Site 1

Vienna, Austria

Location

Boehringer Ingelheim Investigational Site 2

Vienna, Austria

Location

Boehringer Ingelheim Investigational Site 3

Vienna, Austria

Location

Boehringer Ingelheim Investigational Site 4

Wels, Austria

Location

Boehringer Ingelheim Investigational Site 7

Bialystok, Poland

Location

Boehringer Ingelheim Investigational Site 8

Bialystok, Poland

Location

Boehringer Ingelheim Investigational Site 10

Bydgoszcz, Poland

Location

Boehringer Ingelheim Investigational Site 9

Bydgoszcz, Poland

Location

Boehringer Ingelheim Investigational Site 11

Chorzów, Poland

Location

Boehringer Ingelheim Investigational Site 12

Chorzów, Poland

Location

Boehringer Ingelheim Investigational Site 13

Gdañsk, Poland

Location

Boehringer Ingelheim Investigational Site 14

Gdañsk, Poland

Location

Boehringer Ingelheim Investigational Site 15

Gdañsk, Poland

Location

Boehringer Ingelheim Investigational Site 16

Krakow, Poland

Location

Boehringer Ingelheim Investigational Site 17

Krakow, Poland

Location

Boehringer Ingelheim Investigational Site 18

Poznañ, Poland

Location

Boehringer Ingelheim Investigational Site 19

Wroc£aw, Poland

Location

Boehringer Ingelheim Investigational Site 20

Wroc£aw, Poland

Location

Boehringer Ingelheim Investigational Site 50

Bacau, Romania

Location

Boehringer Ingelheim Investigational Site 51

Brasov, Romania

Location

Boehringer Ingelheim Investigational Site 52

Brasov, Romania

Location

Boehringer Ingelheim Investigational Site 53

Brasov, Romania

Location

Boehringer Ingelheim Investigational Site 21

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 22

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 23

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 24

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 25

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 26

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 27

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 28

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 29

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 30

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 31

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 32

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 33

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 34

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 35

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 36

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 37

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 38

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 39

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 40

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 41

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 42

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 43

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 44

Bucharest, Romania

Location

Boehringer Ingelheim Investigational Site 46

Constanța, Romania

Location

Boehringer Ingelheim Investigational Site 47

Constanța, Romania

Location

Boehringer Ingelheim Investigational Site 48

Constanța, Romania

Location

Boehringer Ingelheim Investigational Site 45

Giurgiu, Romania

Location

Boehringer Ingelheim Investigational Site 49

Ploieşti, Romania

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: February 2, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 2, 2015
• Results First Posted: June 2, 2015

Record last verified: 2015-06

Locations

RO (33); PL (14); AU (6)