In vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors - Scientific guideline

This document reviews recent experiments with in vitro investigations of mitochondrial toxicity of nucleoside/nucleotide reverse transcriptase inhibitors in cell culture models. It provides some principles to consider for the conduct of such studies in order to ensure consistency in testing.

Keywords: Mitochondrial toxicity, NRTI, mitochondria, cell culture, in vitro, HIV, HAART, study design

Current version

Draft reflection paper on in vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors

Draft: consultation closed Consultation dates: 13/12/2007 to 30/06/2008 Reference Number: EMEA/CHMP/SWP/8212/2007

Concept paper on the development of a Committee for Medicinal Products for Human Use (CHMP) guideline on the in-vitro investigation of mitochondrial toxicity of anti-HIV medicinal products

Reference Number: EMEA/CHMP/SWP/151915/2004