Clinical trial NCT01524900: Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
Official title: Observational Study Assessing the Safety, Efficacy and Treatment Adherence of Nevirapine Extended Release (Combined With Other Antiretroviral Drugs) in HIV Infected Patients in Daily Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-1 infected patients

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation
timeFrame: up to 72 weeks
measure: Number of Patients Reporting Rash of Any Severity
timeFrame: up to 72 weeks
measure: Number of Patients Reporting Hepatic Events
timeFrame: up to 72 weeks
Secondary outcomes:
measure: Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)
timeFrame: 24 weeks
measure: Change in CD4+ Cell Count From Baseline to Week 24
timeFrame: baseline and week 24
measure: Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks
timeFrame: baseline and week 24
measure: Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Boehringer Ingelheim Investigational Site 6
city: Salzburg
country: Austria
facility: Boehringer Ingelheim Investigational Site 5
city: Vienna
country: Austria
facility: Boehringer Ingelheim Investigational Site 1
city: Vienna
country: Austria
facility: Boehringer Ingelheim Investigational Site 2
city: Vienna
country: Austria
facility: Boehringer Ingelheim Investigational Site 3
city: Wels
country: Austria
facility: Boehringer Ingelheim Investigational Site 4
city: Bialystok
country: Poland
facility: Boehringer Ingelheim Investigational Site 7
city: Bialystok
country: Poland
facility: Boehringer Ingelheim Investigational Site 8
city: Bydgoszcz
country: Poland
facility: Boehringer Ingelheim Investigational Site 10
city: Bydgoszcz
country: Poland
facility: Boehringer Ingelheim Investigational Site 9
city: Chorzów
country: Poland
facility: Boehringer Ingelheim Investigational Site 11
city: Chorzów
country: Poland
facility: Boehringer Ingelheim Investigational Site 12
city: Gdañsk
country: Poland
facility: Boehringer Ingelheim Investigational Site 13
city: Gdañsk
country: Poland
facility: Boehringer Ingelheim Investigational Site 14
city: Gdañsk
country: Poland
facility: Boehringer Ingelheim Investigational Site 15
city: Kraków
country: Poland
facility: Boehringer Ingelheim Investigational Site 16
city: Kraków
country: Poland
facility: Boehringer Ingelheim Investigational Site 17
city: Poznañ
country: Poland
facility: Boehringer Ingelheim Investigational Site 18
city: Wroc£aw
country: Poland
facility: Boehringer Ingelheim Investigational Site 19
city: Wroc£aw
country: Poland
facility: Boehringer Ingelheim Investigational Site 20
city: Bacau
country: Romania
facility: Boehringer Ingelheim Investigational Site 50
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational Site 51
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational Site 52
city: Brasov
country: Romania
facility: Boehringer Ingelheim Investigational Site 53
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 21
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 22
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 23
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 24
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 25
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 26
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 27
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 28
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 29
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 30
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 31
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 32
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 33
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 34
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 35
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 36
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 37
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 38
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 39
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 40
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 41
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 42
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 43
city: Bucuresti
country: Romania
facility: Boehringer Ingelheim Investigational Site 44
city: Constanta
country: Romania
facility: Boehringer Ingelheim Investigational Site 46
city: Constanta
country: Romania
facility: Boehringer Ingelheim Investigational Site 47
city: Constanta
country: Romania
facility: Boehringer Ingelheim Investigational Site 48
city: Giurgiu
country: Romania
facility: Boehringer Ingelheim Investigational Site 45
city: Ploiesti
country: Romania
facility: Boehringer Ingelheim Investigational Site 49
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: