Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142337
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2005-09-01
Brief Title:
One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
A Phase 2 One Arm Open Label Feasibility Study Assessing One Month ZidovudineDidanosine Postpartum Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine to Prevent Mother to Child Transmission of HIV
Status:
COMPLETED
Status Verified Date:
2012-01
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:
The purpose of this study is to determine whether providing zidovudine ZDV and didanosine ddI during labor and for one month postpartum can reduce the selection of nevirapine NVP resistance mutations postpartum in women who received a single dose of nevirapine during labor and standard ZDV prophylaxis for the prevention of mother to child transmission of HIV
Detailed Description:
A single nevirapine dose to the mother with or without a dose to the child in addition to oral ZDV prophylaxis starting from 28 weeks gestation has been proven to be highly effective in reducing further mother-to-child HIV transmission PMTCT
However post exposure nevirapine resistance mutations are observed in the mothers viral population These mutations detectable very early after exposure tend to disappear over time
Nevertheless they may be associated with decrease in efficacy of non-nucleoside reverse transcriptase inhibitor NNRTI containing regimens subsequently given to the women for their own health
Therefore there is a need for research to prevent selection of resistance in the first place or to overcome the resistance in subsequent treatment of the infected mother or infant
Nevirapine plasma levels above IC50 have been detected in women exposed to a single 200 mg dose of nevirapine in a significant number of women during the third week postpartum
We hypothesize that giving ZDVddI to women exposed to nevirapine for one month as soon as possible after exposure may prevent the selection of nevirapine resistance mutations
However post exposure nevirapine resistance mutations are observed in the mothers viral population These mutations detectable very early after exposure tend to disappear over time
Nevertheless they may be associated with decrease in efficacy of non-nucleoside reverse transcriptase inhibitor NNRTI containing regimens subsequently given to the women for their own health
Therefore there is a need for research to prevent selection of resistance in the first place or to overcome the resistance in subsequent treatment of the infected mother or infant
Nevirapine plasma levels above IC50 have been detected in women exposed to a single 200 mg dose of nevirapine in a significant number of women during the third week postpartum
We hypothesize that giving ZDVddI to women exposed to nevirapine for one month as soon as possible after exposure may prevent the selection of nevirapine resistance mutations
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