Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294892
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2006-02-21
Brief Title:
Pharmacokinetics Study on Nevirapine Resistance in Tanzania
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
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 nevirapinecarbamazepine
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 nevirapinecarbamazepine
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:
None
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?:
None