Last reviewed · How we verify
The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)
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.
Details
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 144 |
| Start date | 2006-02 |
| Completion | 2010-06 |
Conditions
- HIV Infections
Interventions
- carbamazepine and nevirapine
- Nevirapine
Primary outcomes
- Cord blood will be taken less than 30 minutes after delivery — 0 - 30 min after delivery
- Blood samples from mother will be taken less than 30 minutes after delivery to measure viral load and CD4 count. — 0 - 30 min after delivery
- Blood samples will be drawn from mother and child at week 1 (day 6-8), week 2 (day 13-15) and week 3 (day 20-22) — day 6 - 22 after delivery
- From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns. — 0 30 min after delivery - week 3 after delivery
Countries
Tanzania