Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028145
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2001-12-13
Brief Title:
Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Organization:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study Overview
Official Title:
Perinatal Core Protocol
Status:
COMPLETED
Status Verified Date:
2014-10
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:
The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children
The rate of transmission of HIV from mothers to their infants has gone down Specific US Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies but the effectiveness of treatment and safety for the mother and her infant have not been fully examined This study will monitor the health of women and their infants while they receive anti-HIV therapy Also this study will provide information that may be used for future studies
The rate of transmission of HIV from mothers to their infants has gone down Specific US Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies but the effectiveness of treatment and safety for the mother and her infant have not been fully examined This study will monitor the health of women and their infants while they receive anti-HIV therapy Also this study will provide information that may be used for future studies
Detailed Description:
The current low rate of vertical transmission of HIV in the US limits the number and types of questions concerning transmission risk and pathogenesis that can be addressed by a single clinical trial Specific US Public Health Service guidelines recommend antiretroviral therapy ART during pregnancy to maximize health of women However data regarding the effectiveness and safety of and adherence to ART during pregnancy are limited It is both appropriate and necessary for theInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group IMPAACT to recruit pregnant women into a non-interventional analytic epidemiologic study to methodically collect clinical and laboratory data from them and their infants This way the IMPAACT can achieve the aims of evaluating management of HIV-infected women during pregnancy and determining the safety and effectiveness of ART and other interventions intended to prevent vertical transmission andor improve maternal health In addition longitudinally collected core protocol data and repository specimens will enable future substudies
Participants receive no protocol specific treatment or other intervention as part of this study The study involves the follow-up of HIV-infected women enrolled during pregnancy or at the time of delivery for 6 months postpartum and their infants for the first 6 months of life There will be 8 study visits for enrolled participants and 6 study visits for infants Data concerning ART use adherence to medications and review of symptoms relevant to side effects and toxicities are collected through administration of questionnaires at all maternal visits Phlebotomy is conducted to obtain specimens for a repository and for required laboratory tests During labor and delivery maternal blood is obtained for lymphocyte subset and viral load assays and for repository storage Collection of amniotic fluid at the time of cesarean section is encouraged These collections are submitted to a central repository Data for the core protocol are abstracted from the infants medical record at the time of birth and at each postnatal visit
Participants receive no protocol specific treatment or other intervention as part of this study The study involves the follow-up of HIV-infected women enrolled during pregnancy or at the time of delivery for 6 months postpartum and their infants for the first 6 months of life There will be 8 study visits for enrolled participants and 6 study visits for infants Data concerning ART use adherence to medications and review of symptoms relevant to side effects and toxicities are collected through administration of questionnaires at all maternal visits Phlebotomy is conducted to obtain specimens for a repository and for required laboratory tests During labor and delivery maternal blood is obtained for lymphocyte subset and viral load assays and for repository storage Collection of amniotic fluid at the time of cesarean section is encouraged These collections are submitted to a central repository Data for the core protocol are abstracted from the infants medical record at the time of birth and at each postnatal visit
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 |
|---|---|---|---|
| U01AI068632 | NIH | None | httpsreporternihgovquickSearchU01AI068632 |