Pharmacokinetics Study on Nevirapine Resistance in Tanzania

Status Completed

Clinical Trial 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.

Clinical Trial Description

Without the use of preventative measures, the risk of mother-to-child transmission (MTCT) of HIV-1 is estimated to vary between 25 and 48%. The regimen of single dose of nevirapine to the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72 hours after birth reduces the risk of MTCT by 50%, is affordable in many situations and is therefore standard of care in many African countries, like Tanzania. Recent studies, however, have shown that this single dose to the mother can induce the occurrence of nevirapine resistance in a large number of mothers. The mechanism of occurrence of nevirapine resistance already after a single dose is most likely related to the long elimination half-life of the drug. The subtherapeutic plasma levels present the perfect environment for the occurrence of resistance as the concentrations are subinhibitory for several days. ;

Study Design

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT00294892
Study type	Interventional
Source	Radboud University
Contact
Status	Completed
Phase	Phase 2
Start date	February 2006
Completion date	June 2010

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