N/A
Completed N=387
Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice
Source: ClinicalTrials.gov NCT01524900 ↗Enrolled (actual)
387
Serious AEs
0.5%
Results posted
Jun 2015
Primary outcomePrimary: Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation — 0; 4; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation |
0; 4; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients Reporting Rash of Any Severity |
0; 0; 0; 0; 0 | — |
| PRIMARY Number of Patients Reporting Hepatic Events |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) |
21; 150; 15; 3; 11; 3 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 24 |
19.6; 98.9; 73.5; 31.2; 135.9 | — |
| SECONDARY Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks |
0.3; 0.4; 0.7; 0.8; -0.1 | — |
| SECONDARY Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation |
4; 41; 6; 4; 7; 29 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01524900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.