Pharmacokinetics Study on Nevirapine Resistance in Tanzania
|ClinicalTrials.gov Identifier: NCT00294892|
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : May 31, 2012
- 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
* safety of single dose nevirapine and nevirapine/carbamazepine
Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive pregnant Tanzanian women by decreasing nevirapine half-life.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: carbamazepine and nevirapine Drug: Nevirapine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||June 2010|
Active Comparator: Carbamazepine
An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery
Drug: carbamazepine and nevirapine
Carbamazepine 400mg and Nevirapine 200mg are taken just before delivery during labor.
Placebo Comparator: Nevirapine
Standard therapy of 200mg Nevirapine oral prior to delivery
Nevirapine 200mg is taken prior to delivery during labor.
- Cord blood will be taken less than 30 minutes after delivery [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: day 6 - 22 after delivery ]
- From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns. [ Time Frame: 0 30 min after delivery - week 3 after delivery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294892
|Kilimanjaro Christian Medical College|
|Principal Investigator:||David M. Burger, Dr.||Radboud University (RUNMC)|