Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334256
Status:
COMPLETED
Last Update Posted:
2011-12-05
First Post:
2006-06-06
Brief Title:
TenofovirEmtricitabine for PMTCT in Africa and Asia ANRS 12109 TEmAA
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Phase II Trial Multicentre Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia
Status:
COMPLETED
Status Verified Date:
2011-12
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:
TEmAA
Brief Summary:
To study the pharmacokinetic properties safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their newborns with a view to prevention of mother-to-child transmission PMTCT of HIV-1 in Africa and Asia
Detailed Description:
Single-dose nevirapine sdNVP is the option of choice for the prevention of mother-to-child transmission PMTCT of HIV-1 in countries with limited resources However the use of sdNVP results in resistance mutations with an estimated frequency at of least 15 to 70 in women at W4-W6 postpartum These mutations could compromise the success of subsequent treatments of mother and child with antiretroviral combinations that include NVP Pre-clinical and clinical studies suggest that a combination of TDF and FTC drugs with interesting pharmacokinetic properties that may be a useful alternative or complement to sdNVP
The objectives are to study the pharmacokinetic properties safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate TDF 600 mg and emtricitabine FTC 400 mg in HIV-1-infected pregnant women and their newborns with a view to prevention of mother-to-child transmission PMTCT of HIV-1 in Africa and Asia
Phase II trial multicentre open-label will be conducted in two steps with 30 mother-infant pairs per step and with a balanced allocation in Abidjan Côte dIvoire Soweto South Africa and Phnom Penh Cambodia
Step 1 administration of TDFFTC to the mother Step 2 administration of TDFFTC to the mother and the newborn
The objectives are to study the pharmacokinetic properties safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate TDF 600 mg and emtricitabine FTC 400 mg in HIV-1-infected pregnant women and their newborns with a view to prevention of mother-to-child transmission PMTCT of HIV-1 in Africa and Asia
Phase II trial multicentre open-label will be conducted in two steps with 30 mother-infant pairs per step and with a balanced allocation in Abidjan Côte dIvoire Soweto South Africa and Phnom Penh Cambodia
Step 1 administration of TDFFTC to the mother Step 2 administration of TDFFTC to the mother and the newborn
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