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Pharmacokinetics Study on Nevirapine Resistance in Tanzania

NCT00294892 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2020-11-30

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

carbamazepine and nevirapine

Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.

DRUG

Nevirapine

Nevirapine 200mg is taken prior to delivery during labor.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • David M. Burger, Dr. · Radboud University (RUNMC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-09-30
Completion
2010-06-30

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294892 on ClinicalTrials.gov