Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041964
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2002-07-19
Brief Title:
A Study of HIV Levels During Pregnancy and After Childbirth
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Prospective Observational Study of Virologic and Immunologic Changes in HIV-Infected Women During the Postpartum Period
Status:
COMPLETED
Status Verified Date:
2012-07
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 find out if HIV-infected pregnant women taking anti-HIV drugs have an increased amount of HIV in their blood viral load after having the baby
The purpose of A5153s a substudy of A5150 is to characterize two anti-HIV drugs nelfinavir NFV and lopinavirritonavir LPVr in HIV-infected women during pregnancy and after childbirth
Sometimes pregnant women have an increase in their HIV viral load after their baby is born This study will try to find out how often this happens It will also examine possible reasons why the increase in viral load occurs
The purpose of A5153s a substudy of A5150 is to characterize two anti-HIV drugs nelfinavir NFV and lopinavirritonavir LPVr in HIV-infected women during pregnancy and after childbirth
Sometimes pregnant women have an increase in their HIV viral load after their baby is born This study will try to find out how often this happens It will also examine possible reasons why the increase in viral load occurs
Detailed Description:
Limited data suggest that HIV-infected pregnant women develop postpartum viral rebound However viral load changes in the postpartum period have not been adequately characterized Changes in adherence to antiretroviral therapy pregnancy-related changes in pharmacokinetics of antiretroviral medications and decline in immune competence are mechanisms by which postpartum viral load rebound may occur This study is designed to characterize the incidence and magnitude of postpartum viral rebound during the initial 24 weeks postpartum and to explore the mechanisms and consequences of viral rebound
Eligible patients are evaluated at gestational weeks 34 and 36 at delivery and at regular visits for 96 weeks postpartum Most evaluations include a medical history physical exam laboratory tests and adherence and quality-of-life questionnaires Viral load and CD4CD8 cell counts are measured frequently
Patients are expected to receive at least 8 weeks of stable HAART before delivery and to continue HAART throughout the remainder of the study The choice of HAART is left to the primary provider No antiretroviral drugs are provided by this study
Patients participating in the A5153s substudy receive either NFV or LPVr as part of their HAART Pharmacokinetic blood sampling takes place at 36 weeks gestation 6 weeks postpartum and 24 weeks postpartum Patients record the administration times and doses of their NFV or LPVr for 48 hours prior to each substudy visit and hold their regularly scheduled doses of antiretroviral medications on substudy days Patients arrive at the clinic fasting no food or drink for the previous 8 hours and are given a standardized breakfast prior to supervised administration of their NFV or LPVr dose An intravenous catheter is placed in an arm vein for blood collection at pre-dose and 1 2 4 and 6 hours post-dose
Eligible patients are evaluated at gestational weeks 34 and 36 at delivery and at regular visits for 96 weeks postpartum Most evaluations include a medical history physical exam laboratory tests and adherence and quality-of-life questionnaires Viral load and CD4CD8 cell counts are measured frequently
Patients are expected to receive at least 8 weeks of stable HAART before delivery and to continue HAART throughout the remainder of the study The choice of HAART is left to the primary provider No antiretroviral drugs are provided by this study
Patients participating in the A5153s substudy receive either NFV or LPVr as part of their HAART Pharmacokinetic blood sampling takes place at 36 weeks gestation 6 weeks postpartum and 24 weeks postpartum Patients record the administration times and doses of their NFV or LPVr for 48 hours prior to each substudy visit and hold their regularly scheduled doses of antiretroviral medications on substudy days Patients arrive at the clinic fasting no food or drink for the previous 8 hours and are given a standardized breakfast prior to supervised administration of their NFV or LPVr dose An intravenous catheter is placed in an arm vein for blood collection at pre-dose and 1 2 4 and 6 hours post-dose
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 |
|---|---|---|---|
| AACTG A5153s | None | None | None |
| ACTG A5153s | None | None | None |
| AACTG A5150 | None | None | None |