Long-term Study in Patients Under Anti-retroviral Combination Therapy Switching to Viramune®

N/ACompletedNCT02191293

Boehringer Ingelheim228 enrolled

Overview

Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

Study Type

OBSERVATIONAL

Enrollment

228

Conditions

HIV Infections

Interventions

Viramune® tabletsDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult male and female out-patients with HIV type 1 infection who have achieved a viral load below detection limit (50 copies/ml) for more than 6 months under a previous combination therapy with protease-inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) * Women can only be included, if a test has excluded pregnancy * Only women can be included, who use a reliable means of contraception during the observational study Exclusion Criteria: * Known sensitivity to Viramune or one of its excipients * Clinically relevant changes in lab findings (e.g. increase in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) by more than five-fold of upper limit normal) * Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, and other medication CYP3A metabolism * For females: * Pregnancy * Breast-feeding * Insufficient or unreliable contraception