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

1 juin 2015 mis à jour par: Boehringer Ingelheim

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

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Infections à VIH

Description détaillée

Study Design:

non-interventional uncontrolled observational study

Type d'étude

Observationnel

Inscription (Réel)

398

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 64 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

HIV-1 infected patients

La description

Inclusion criteria:

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.

Exclusion criteria:

Consistent with the current VIRAMUNE prolonged release SPC.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
nevirapine extended release

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation Délai: up 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.	up to 72 weeks
Number of Patients Reporting Rash of Any Severity Délai: up to 72 weeks	Number of patients reporting rash of any severity as adverse event	up to 72 weeks
Number of Patients Reporting Hepatic Events Délai: up 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.	up to 72 weeks

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) Délai: 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.	24 weeks
Change in CD4+ Cell Count From Baseline to Week 24 Délai: baseline 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.	baseline and week 24
Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks Délai: baseline 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.	baseline and week 24
Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation Délai: 24 weeks	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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Boehringer Ingelheim

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Related Info

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2012

Achèvement primaire (Réel)

1 mai 2014

Achèvement de l'étude (Réel)

1 mai 2014

Dates d'inscription aux études

Première soumission

17 janvier 2012

Première soumission répondant aux critères de contrôle qualité

31 janvier 2012

Première publication (Estimation)

2 février 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 juin 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2015

Dernière vérification