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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524900
• Other study ID #: 1100.1550
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: June 1, 2015
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Medicines and Medical Devices AgencyPoland: Registration Medicinal Product Medical Device Biocidal ProductRomania: National Medicines Agency
• Study type: Observational

Clinical Trial 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.

Description:

Study Design:

non-interventional uncontrolled observational study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Locations

Country	Name	City	State
Austria	Boehringer Ingelheim Investigational Site 6	Graz
Austria	Boehringer Ingelheim Investigational Site 5	Salzburg
Austria	Boehringer Ingelheim Investigational Site 1	Vienna
Austria	Boehringer Ingelheim Investigational Site 2	Vienna
Austria	Boehringer Ingelheim Investigational Site 3	Vienna
Austria	Boehringer Ingelheim Investigational Site 4	Wels
Poland	Boehringer Ingelheim Investigational Site 7	Bialystok
Poland	Boehringer Ingelheim Investigational Site 8	Bialystok
Poland	Boehringer Ingelheim Investigational Site 10	Bydgoszcz
Poland	Boehringer Ingelheim Investigational Site 9	Bydgoszcz
Poland	Boehringer Ingelheim Investigational Site 11	Chorzów
Poland	Boehringer Ingelheim Investigational Site 12	Chorzów
Poland	Boehringer Ingelheim Investigational Site 13	Gdañsk
Poland	Boehringer Ingelheim Investigational Site 14	Gdañsk
Poland	Boehringer Ingelheim Investigational Site 15	Gdañsk
Poland	Boehringer Ingelheim Investigational Site 16	Kraków
Poland	Boehringer Ingelheim Investigational Site 17	Kraków
Poland	Boehringer Ingelheim Investigational Site 18	Poznañ
Poland	Boehringer Ingelheim Investigational Site 19	Wroc£aw
Poland	Boehringer Ingelheim Investigational Site 20	Wroc£aw
Romania	Boehringer Ingelheim Investigational Site 50	Bacau
Romania	Boehringer Ingelheim Investigational Site 51	Brasov
Romania	Boehringer Ingelheim Investigational Site 52	Brasov
Romania	Boehringer Ingelheim Investigational Site 53	Brasov
Romania	Boehringer Ingelheim Investigational Site 21	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 22	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 23	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 24	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 25	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 26	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 27	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 28	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 29	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 30	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 31	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 32	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 33	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 34	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 35	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 36	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 37	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 38	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 39	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 40	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 41	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 42	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 43	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 44	Bucuresti
Romania	Boehringer Ingelheim Investigational Site 46	Constanta
Romania	Boehringer Ingelheim Investigational Site 47	Constanta
Romania	Boehringer Ingelheim Investigational Site 48	Constanta
Romania	Boehringer Ingelheim Investigational Site 45	Giurgiu
Romania	Boehringer Ingelheim Investigational Site 49	Ploiesti

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Number of Patients Reporting Rash of Any Severity	Number of patients reporting rash of any severity as adverse event	up to 72 weeks	Yes
Primary	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	Yes
Secondary	Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)	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.	24 weeks	No
Secondary	Change in CD4+ Cell Count From Baseline to 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.	baseline and week 24	No
Secondary	Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks	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.	baseline and week 24	No
Secondary	Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation	The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.	24 weeks	No

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