Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100867
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2005-01-06
Brief Title:
Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World
Status:
COMPLETED
Status Verified Date:
2016-03
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:
In clinical trials being conducted throughout the world pregnant HIV-infected women are given anti-HIV drugs before during and after they give birth to prevent mother-to-child transmission of HIV However the effects of this anti-HIV treatment on infants is unknown The purpose of this study is to determine the safety toxicity and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women
Study hypothesis Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods and are not associated with adverse side effects to the fetus neonate andor breastfeeding infant These regimens are associated with reduction of mother-to-child HIV transmission
Study hypothesis Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods and are not associated with adverse side effects to the fetus neonate andor breastfeeding infant These regimens are associated with reduction of mother-to-child HIV transmission
Detailed Description:
Many HIV-infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy ART to prevent mother-to-child transmission of HIV However data are limited on the safety toxicity and adverse effects that maternal ART may have on infants born to HIV-infected women This study will monitor the adverse effects and potential benefits of maternal ART on these infants
No antiretrovirals will be given in this study This study will last 18 months Infants will be enrolled in the study within 48 hours of birth There will be 6 study visits starting at study entry and every 6 weeks thereafter Infants will undergo blood and urine collection and medical history assessments will occur at every visit Mothers will also be evaluated at these visits
No antiretrovirals will be given in this study This study will last 18 months Infants will be enrolled in the study within 48 hours of birth There will be 6 study visits starting at study entry and every 6 weeks thereafter Infants will undergo blood and urine collection and medical history assessments will occur at every visit Mothers will also be evaluated at these visits
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 |
|---|---|---|---|
| 1U01AI068636 | NIH | None | httpsreporternihgovquickSearch1U01AI068636 |