Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120471
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-07-14
Brief Title:
Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies
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 Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate 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:
To prevent mother-to-child transmission MTCT of HIV in resource-limited countries a simple yet effective treatment plan is needed Tenofovir disoproxil fumarate TDF is an anti-HIV drug approved for use in the United States for the treatment of HIV infected adults The purpose of this study is to determine the safety tolerability and blood levels of TDF in HIV infected pregnant women and their babies The study will be conducted at sites in Malawi and Brazil
Detailed Description:
Rates of MTCT of HIV have dramatically decreased in resource-rich countries since the introduction of antiretroviral ARV prophylaxis increased prenatal care HIV testing and counseling elective cesarean delivery and avoidance of breastfeeding In resource-limited countries however MTCT of HIV continues to be a widespread problem In these parts of the world ARV prophylaxis is too expensive and too difficult to adequately administer mothers often do not receive proper prenatal care cesarean delivery may pose risks to the mother and and her infant and due to the lack of safe affordable and socially acceptable alternatives HIV infected mothers breastfeed their infants The purpose of this study is to evaluate the safety tolerability and pharmacokinetics PK of TDF in HIV infected pregnant women and their infants
Participants in this study will be enrolled through 12 months after delivery During the last trimester of pregnancy HIV infected women will be screened for eligibility Women will be enrolled into the study upon presentation at the study site for delivery Standard of care with ARVs for prevention of MTCT will be offered to all women and their infants both inside and outside of the study however such ARVs will not be provided by this study
There will be four cohorts in this study
Cohort 1 women will receive a single dose of TDF SD TDF during active labor Cohort 1 women will be hospitalized at the delivery facility through Day 3 postpartum
Cohort 2 women will not receive any TDF Cohort 2 women will be hospitalized at the delivery facility through Day 7 postpartum Their infants will receive TDF at birth and on Days 3 and 5 after birth
Cohort 3 will not begin enrolling women until data safety evaluations of Cohorts 1 and 2 are completed Cohort 3 women will be hospitalized at the delivery facility through Day 7 postpartum Women in Cohort 3 will receive SD TDF during active labor and their infants will receive TDF at birth and on Days 3 and 5 after birth
Cohort 4 which was added to the study based on a review of data from the other cohorts will be similar to Cohort 3 except that infants will receive daily TDF for the 7 days after birth Researchers believe this higher and more frequent dosing of TDF in infants will help them meet the target TDF concentration specified in the protocol
There will be seven study visits for women at study entry Day 0 Day 2 between Days 5 and 7 at Weeks 6 and 12 and at Months 6 and 12 postpartum Medical history a short physical exam and blood collection will occur at all visits In Cohorts 1 3 and 4 blood collection for PK studies will occur prior to receiving TDF and seven times post-dose
There will be eight study visits for infants which will occur within 24 hours of birth on Day 3 between Days 5 and 7 at Weeks 6 and 12 and at Months 6 9 and 12 Medical history a physical exam and blood collection will occur at all visits Infants will have x-rays to assess bone health at Day 3 and Month 3 except in Cohort 4 which will not include x-rays of infants Infants of Cohort 1 will have blood collection for PK studies at birth and four times after birth Infants of Cohorts 2 and 3 will undergo blood collections for PK studies at birth Day 3 and Day 5 Blood collection at these visits will occur before receiving TDF and 2 and 10 hours after receiving TDF At birth an additional collection will occur 18 to 24 hours after receiving TDF and on Day 5 two additional collections will occur--at 18 to 24 hours and at 36 to 48 hours after receiving TDF Infants of Cohort 4 will have blood collection for PK studies at birth and after their fourth and seventh doses of TDF
Participants in this study will be enrolled through 12 months after delivery During the last trimester of pregnancy HIV infected women will be screened for eligibility Women will be enrolled into the study upon presentation at the study site for delivery Standard of care with ARVs for prevention of MTCT will be offered to all women and their infants both inside and outside of the study however such ARVs will not be provided by this study
There will be four cohorts in this study
Cohort 1 women will receive a single dose of TDF SD TDF during active labor Cohort 1 women will be hospitalized at the delivery facility through Day 3 postpartum
Cohort 2 women will not receive any TDF Cohort 2 women will be hospitalized at the delivery facility through Day 7 postpartum Their infants will receive TDF at birth and on Days 3 and 5 after birth
Cohort 3 will not begin enrolling women until data safety evaluations of Cohorts 1 and 2 are completed Cohort 3 women will be hospitalized at the delivery facility through Day 7 postpartum Women in Cohort 3 will receive SD TDF during active labor and their infants will receive TDF at birth and on Days 3 and 5 after birth
Cohort 4 which was added to the study based on a review of data from the other cohorts will be similar to Cohort 3 except that infants will receive daily TDF for the 7 days after birth Researchers believe this higher and more frequent dosing of TDF in infants will help them meet the target TDF concentration specified in the protocol
There will be seven study visits for women at study entry Day 0 Day 2 between Days 5 and 7 at Weeks 6 and 12 and at Months 6 and 12 postpartum Medical history a short physical exam and blood collection will occur at all visits In Cohorts 1 3 and 4 blood collection for PK studies will occur prior to receiving TDF and seven times post-dose
There will be eight study visits for infants which will occur within 24 hours of birth on Day 3 between Days 5 and 7 at Weeks 6 and 12 and at Months 6 9 and 12 Medical history a physical exam and blood collection will occur at all visits Infants will have x-rays to assess bone health at Day 3 and Month 3 except in Cohort 4 which will not include x-rays of infants Infants of Cohort 1 will have blood collection for PK studies at birth and four times after birth Infants of Cohorts 2 and 3 will undergo blood collections for PK studies at birth Day 3 and Day 5 Blood collection at these visits will occur before receiving TDF and 2 and 10 hours after receiving TDF At birth an additional collection will occur 18 to 24 hours after receiving TDF and on Day 5 two additional collections will occur--at 18 to 24 hours and at 36 to 48 hours after receiving TDF Infants of Cohort 4 will have blood collection for PK studies at birth and after their fourth and seventh doses of TDF
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 |
|---|---|---|---|
| 10143 | REGISTRY | DAIDS-ES | None |