Pharmacokinetics Study on Nevirapine Resistance in Tanzania

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Carbamazepine; Nevirapine

Criteria

Inclusion Criteria:

• HIV infected

• antiretroviral naive

• not intending to relocate out of area during study

• willing to adhere to follow up scheme

• ability and willing to give written consent

• pregnant between 18 and 40 years

• willing and able to regularly attend the Antenatal clinic

Exclusion Criteria:

• serious illness that requires systemic treatment or hospitalization

• any condition that would compromise subject's ability to participate

• previously treated for HIV with antiretroviral agents, including single dose nevirapine used for MTCT

• inability to understand the nature and extent of the trial and procedures