Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204308
Status:
COMPLETED
Last Update Posted:
2012-05-31
First Post:
2005-09-12
Brief Title:
Maternal TDF and FTC to Reduce NNRTI Resistance Mutations After Intrapartum NVP
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Addition of Single-dose Maternal Tenofovir and Emtricitabine to Reduce Non-nucleoside Reverse Transcriptase Inhibitor Resistance Mutations in the Setting of Zidovudine and Nevirapine for Prevention of Mother-to-child HIV Transmission
Status:
COMPLETED
Status Verified Date:
2012-05
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:
TD-2
Brief Summary:
The purpose of this study is to determine whether the addition of tenofovir TDF and emtricitabine FTCto a standard PMTCT regimen containing single-dose nevirapine NVP can reduce the development of post-ingestion HIV resistance to non-nucleoside reverse transcriptase inhibitors NNRTIs
Detailed Description:
Single-dose intrapartum and neonatal nevirapine NVP either alone or in combination with short course zidovudine ZDV is in widespread use to prevent mother-to-child HIV transmission throughout the developing world Though the public health benefits cannot be overstated widespread use of NVP in this fashion may come at a cost Non-nucleoside reverse transcriptase inhibitor NNRTI resistance mutations are induced in at least 20 and probably a larger proportion of women exposed to NVP in this fashion Addition of short-course ZDV does not appear to mitigate this effect substantially The full implications of these NVP resistance mutations are yet unknown though there is concern that they may result in reduced efficacy of the NVP or other NNRTIs in long-term therapeutic regimens
We are conducting a clinical trial of tenofovir TDF and emtricitabine FTC marketed as a fixed dose combination Truvada to reduce NNRTI-resistance post-delivery in the setting of NVP with or without ZDV for PMTCT TDF and FTC are both Category B drugs and are approved for use in pregnancy They have several characteristics that make them ideal candidate drugs for use in conjunction with NVP including long intracellular half-lives and established safety profile among adults for HIV treatment
Women will be enrolled between 28 and 38 weeks of gestation As part of normal PMTCT services they may choose NVP-boosted ZDV or single dose NVP for PMTCT We anticipate that most 80 will choose the former At arrival for delivery they will be randomized to receive either the two study drugs intervention or no drug control A total of 400 women will be randomized and followed along with their infants for 6 months
We are conducting a clinical trial of tenofovir TDF and emtricitabine FTC marketed as a fixed dose combination Truvada to reduce NNRTI-resistance post-delivery in the setting of NVP with or without ZDV for PMTCT TDF and FTC are both Category B drugs and are approved for use in pregnancy They have several characteristics that make them ideal candidate drugs for use in conjunction with NVP including long intracellular half-lives and established safety profile among adults for HIV treatment
Women will be enrolled between 28 and 38 weeks of gestation As part of normal PMTCT services they may choose NVP-boosted ZDV or single dose NVP for PMTCT We anticipate that most 80 will choose the former At arrival for delivery they will be randomized to receive either the two study drugs intervention or no drug control A total of 400 women will be randomized and followed along with their infants for 6 months
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