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

Completed
Conditions
HIV Infections
Registration Number
NCT01524900
Lead Sponsor
Boehringer Ingelheim
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.

Detailed Description

Study Design:

non-interventional uncontrolled observational study

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
398
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuationup to 72 weeks

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.

Number of Patients Reporting Rash of Any Severityup to 72 weeks

Number of patients reporting rash of any severity as adverse event

Number of Patients Reporting Hepatic Eventsup to 72 weeks

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.

Secondary Outcome Measures
NameTimeMethod
Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)24 weeks

Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of \< 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as 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 is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.

Change in CD4+ Cell Count From Baseline to Week 24baseline and week 24

The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.

Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeksbaseline and week 24

The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.

Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation24 weeks

The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.

Trial Locations

Locations (53)

Boehringer Ingelheim Investigational Site 50

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Bacau, Romania

Boehringer Ingelheim Investigational Site 6

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Graz, Austria

Boehringer Ingelheim Investigational Site 1

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Vienna, Austria

Boehringer Ingelheim Investigational Site 10

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Bydgoszcz, Poland

Boehringer Ingelheim Investigational Site 39

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 5

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Salzburg, Austria

Boehringer Ingelheim Investigational Site 30

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 45

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Giurgiu, Romania

Boehringer Ingelheim Investigational Site 21

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 25

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 49

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Ploiesti, Romania

Boehringer Ingelheim Investigational Site 24

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 43

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 2

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Vienna, Austria

Boehringer Ingelheim Investigational Site 3

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Vienna, Austria

Boehringer Ingelheim Investigational Site 4

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Wels, Austria

Boehringer Ingelheim Investigational Site 7

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Bialystok, Poland

Boehringer Ingelheim Investigational Site 8

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Bialystok, Poland

Boehringer Ingelheim Investigational Site 9

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Bydgoszcz, Poland

Boehringer Ingelheim Investigational Site 11

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Chorzów, Poland

Boehringer Ingelheim Investigational Site 12

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Chorzów, Poland

Boehringer Ingelheim Investigational Site 13

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Gdañsk, Poland

Boehringer Ingelheim Investigational Site 14

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Gdañsk, Poland

Boehringer Ingelheim Investigational Site 16

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Kraków, Poland

Boehringer Ingelheim Investigational Site 15

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Gdañsk, Poland

Boehringer Ingelheim Investigational Site 17

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Kraków, Poland

Boehringer Ingelheim Investigational Site 18

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Poznañ, Poland

Boehringer Ingelheim Investigational Site 19

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Wroc£aw, Poland

Boehringer Ingelheim Investigational Site 20

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Wroc£aw, Poland

Boehringer Ingelheim Investigational Site 51

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Brasov, Romania

Boehringer Ingelheim Investigational Site 52

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Brasov, Romania

Boehringer Ingelheim Investigational Site 53

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Brasov, Romania

Boehringer Ingelheim Investigational Site 22

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 23

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 26

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 27

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 29

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 28

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 31

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 32

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 33

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 34

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 35

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 36

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 37

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 38

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 40

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 41

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 42

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 44

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Bucuresti, Romania

Boehringer Ingelheim Investigational Site 46

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Constanta, Romania

Boehringer Ingelheim Investigational Site 47

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Constanta, Romania

Boehringer Ingelheim Investigational Site 48

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Constanta, Romania

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