Pharmacokinetics Study on Nevirapine Resistance in Tanzania

Summary

Primary * pharmacokinetics of single dose nevirapine * the effect of single dose carbamazepine on the pk of single dose nevirapine * resistance against nevirapine before and after. * follow-up on HIV status newborns * relation between nevirapine levels in cord blood and plasma Secondary \* safety of single dose nevirapine and nevirapine/carbamazepine Hypothesis: Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive pregnant Tanzanian women by decreasing nevirapine half-life.

Timeline

Start

2006-02

Primary completion

2009-09

Completion

2010-06

Publications

• Muro EP, Fillekes Q, Kisanga ER, L'homme R, Aitken SC, Mariki G, Van der Ven AJ, Dolmans W, Schuurman R, Walker AS, Gibb DM, Burger DM. Intrapartum single-dose carbamazepine reduces nevirapine levels faster and may decrease resistance after a single dose of nevirapine for perinatal HIV prevention. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):266-73. doi: 10.1097/QAI.0b013e31824234d8.

Drugs

Indications