Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076791
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-02-03
Brief Title:
Safety of Tenofovir Disoproxil Fumarate TDF and EmtricitabineTDF in HIV Infected Pregnant Women and Their Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study of the Safety Tolerance and Pharmacokinetics of Tenofovir Disoproxil Fumarate TDF and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants
Status:
COMPLETED
Status Verified Date:
2021-10
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:
Most infants infected with HIV through mother-to-child transmission MTCT or perinatal transmission become infected during labor and delivery The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate TDF or emtricitabineTDF FTCTDF given at the time of labor to HIV infected pregnant women and to their newborn infants
Detailed Description:
The majority of perinatally infected infants are infected during the labor and delivery process but recent studies suggest that additional factors such as postexposure prophylaxis are likely to be involved in the prevention of MTCT of HIV It is possible that antiretroviral dosing only during labor and short-term dosing to newly born infants would be sufficiently effective to prevent MTCT of HIV TDF is a nucleoside reverse transcriptase inhibitor that has demonstrated significant effectiveness in preventing MTCT of simian immunodeficiency virus SIV in a primate model of HIV FTCTDF is a combination of two NRTIs being studied because this combination has the potential to prevent MTCT while protecting the mother from developing resistance that may develop with single drug therapy This study will evaluate the safety tolerance and pharmacokinetics PK of single doses of TDF and FTCTDF in both HIV infected pregnant women and their newborn infants
Cohort 1 is now closed Each participant in Cohort 1 received a single 600 mg oral dose of TDF at the start of active labor or 4 hours prior to C-section with concurrent administration of standard intravenous zidovudine ZDV prophylaxis andor other antiretrovirals prescribed by her physician The infants from Cohort 1 received only the standard 6 weeks of oral ZDV prophylaxis postpartum PK blood samples were taken from mothers at predose and 1 2 4 8 12 and 24 hours postdose and at the time of delivery PK blood samples were taken from infants at 12 24 and 36 hours after birth
Pregnant women with HIV infection entering this study will be assigned to Cohort 2 as all infants in Cohort 1 have completed the 6 to 8 week study visit and all Cohort 1 data have been reviewed Mothers in Cohort 2 will receive a single dose of 900 mg of TDF combined with 600 mg emtricitabine along with standard ZDV prophylaxis andor other antiretrovirals prescribed by her physician Infants will receive a single dose of TDF at 4 mgkg combined with 3 mgkg emtricitabine as soon as possible after delivery and within 6 hours of age as well as the standard 6 weeks of oral ZDV prophylaxis after birth Blood samples from mothers and infants will be taken as for Cohort 1
Mothers will be followed for 12 weeks postpartum or for 2 years after giving birth if viral resistance to TDF or FTCTDF is demonstrated at Weeks 1 6 or 12 In addition to the PK studies blood collection will occur around the time of delivery at screening study entry at delivery and after delivery at various times up to Week 12 Physical exams will be done at screening study entry at delivery and after delivery at various times up to Week 8 Infants will be followed until age 2 Blood will be collected and physical exams will be done at birth and at various times up to Week 96 Mothers are encouraged to coenroll in PACTG P1025 Pharmacokinetic Study of Anti-HIV Drugs During Pregnancy
Cohort 1 is now closed Each participant in Cohort 1 received a single 600 mg oral dose of TDF at the start of active labor or 4 hours prior to C-section with concurrent administration of standard intravenous zidovudine ZDV prophylaxis andor other antiretrovirals prescribed by her physician The infants from Cohort 1 received only the standard 6 weeks of oral ZDV prophylaxis postpartum PK blood samples were taken from mothers at predose and 1 2 4 8 12 and 24 hours postdose and at the time of delivery PK blood samples were taken from infants at 12 24 and 36 hours after birth
Pregnant women with HIV infection entering this study will be assigned to Cohort 2 as all infants in Cohort 1 have completed the 6 to 8 week study visit and all Cohort 1 data have been reviewed Mothers in Cohort 2 will receive a single dose of 900 mg of TDF combined with 600 mg emtricitabine along with standard ZDV prophylaxis andor other antiretrovirals prescribed by her physician Infants will receive a single dose of TDF at 4 mgkg combined with 3 mgkg emtricitabine as soon as possible after delivery and within 6 hours of age as well as the standard 6 weeks of oral ZDV prophylaxis after birth Blood samples from mothers and infants will be taken as for Cohort 1
Mothers will be followed for 12 weeks postpartum or for 2 years after giving birth if viral resistance to TDF or FTCTDF is demonstrated at Weeks 1 6 or 12 In addition to the PK studies blood collection will occur around the time of delivery at screening study entry at delivery and after delivery at various times up to Week 12 Physical exams will be done at screening study entry at delivery and after delivery at various times up to Week 8 Infants will be followed until age 2 Blood will be collected and physical exams will be done at birth and at various times up to Week 96 Mothers are encouraged to coenroll in PACTG P1025 Pharmacokinetic Study of Anti-HIV Drugs During Pregnancy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IMPAACT 394 | Registry Identifier | DAIDS ES | None |
| 10034 | REGISTRY | None | None |
| PACTG 394 | None | None | None |