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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01524900
First received: January 17, 2012
Last updated: June 25, 2014
Last verified: June 2014

January 17, 2012
June 25, 2014
March 2012
May 2014   (final data collection date for primary outcome measure)
  • Proportion of patients reporting adverse events [ Time Frame: from signing informed consent till 28days after patient completes the trial ] [ Designated as safety issue: Yes ]
  • Proportion of patients reporting serious adverse events [ Time Frame: from signing informed consent till 28days after patient completes the trial ] [ Designated as safety issue: Yes ]
  • Proportion of patients with adverse events leading to discontinuation [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients reporting rash of any severity [ Time Frame: from signing informed consent till 28days after patient completes the trial ] [ Designated as safety issue: Yes ]
  • Proportion of patients reporting hepatic events of any severity [ Time Frame: from signing informed consent till 28days after patient completes the trial ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01524900 on ClinicalTrials.gov Archive Site
  • Proportion of patients with virologic response at week 24 (viral load <50 copies/mL) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in CD4+ cell count from baseline to week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Change in Morisky Medication Adherence Scale score from baseline to 24 weeks [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients reporting once daily nevirapine more convenient than twice daily formulation [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of respondents reporting once daily nevirapine as "very much more convenient" compared to twice daily formulation [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
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.

Study Design:

non-interventional uncontrolled observational study

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

HIV-1 infected patients

HIV Infections
Not Provided
nevirapine extended release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
398
May 2014
May 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Poland,   Romania
 
NCT01524900
1100.1550
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP