Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-28 @ 10:06 AM
Study NCT ID:
NCT00294892
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2006-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study on Nevirapine Resistance in Tanzania
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
Without the use of preventative measures, the risk of mother-to-child transmission (MTCT) of HIV-1 is estimated to vary between 25 and 48%. The regimen of single dose of nevirapine to the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72 hours after birth reduces the risk of MTCT by 50%, is affordable in many situations and is therefore standard of care in many African countries, like Tanzania. Recent studies, however, have shown that this single dose to the mother can induce the occurrence of nevirapine resistance in a large number of mothers. The mechanism of occurrence of nevirapine resistance already after a single dose is most likely related to the long elimination half-life of the drug. The subtherapeutic plasma levels present the perfect environment for the occurrence of resistance as the concentrations are subinhibitory for several days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: