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

• 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 ]

• 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 ]

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

HIV-1 infected patients

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.