The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this two-phase trial is as follows:
- To determine the elimination half-life of NVP in HIV positive pregnant women receiving
it as a single dose in labour in addition to the ZDV and 3TC with or without seven days
phenytoin (pilot PK phase)
- To determine NVP resistance in HIV positive pregnant women receiving it as a single dose
in labour in addition to ZDV and 3TC with or without seven days phenytoin (main trial
phase)
The secondary objectives of this two-phase trial are as follows:
- To determine the safety of single dose nevirapine with seven days phenytoin as a part of
ARV prophylaxis for PMTCT vs. single dose of nevirapine without phenytoin as a part of
ARV prophylaxis for PMTCT
- To determine the HIV status of the infant
- To determine the safety of the ARV prophylaxis for PMTCT with seven days of phenytoin on
the newborn
Hypothesis: phenytoin reduces the elimination half life of SD NVP and thereby decreases
development of resistance to NVP in HIV positive pregnant Tanzanian and Zambian women.