Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017797
Status:
COMPLETED
Last Update Posted:
2006-08-07
First Post:
2001-06-12
Brief Title:
Problems Associated With the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Metabolic Complications Associated With Antiretroviral Medications in HIV-1-Infected Pregnant Women
Status:
COMPLETED
Status Verified Date:
2006-08
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 who take protease inhibitors PIs are more likely to have blood sugar problems than those who do not take PIs
HIV-infected people generally are treated with a combination of different types of anti-HIV drugs 1 of which is usually a PI The same holds true for pregnant women but not much is known about the use of these drugs in pregnancy Blood sugar and liver problems caused by anti-HIV drugs in nonpregnant patients are well known but their effects in pregnancy are not Also certain physical changes brought about by pregnancy may affect the way drugs are handled in the body There remains a need for further study into the use of anti-HIV drugs during pregnancy and their effect on the safety of the mother and baby
HIV-infected people generally are treated with a combination of different types of anti-HIV drugs 1 of which is usually a PI The same holds true for pregnant women but not much is known about the use of these drugs in pregnancy Blood sugar and liver problems caused by anti-HIV drugs in nonpregnant patients are well known but their effects in pregnancy are not Also certain physical changes brought about by pregnancy may affect the way drugs are handled in the body There remains a need for further study into the use of anti-HIV drugs during pregnancy and their effect on the safety of the mother and baby
Detailed Description:
The dramatic impact of potent combination antiretroviral therapies on the course of HIV disease has made the use of PIs routine in the care of HIV-1-infected individuals Combination therapy likewise has become the standard of care in pregnant individuals even though information on use of these drugs during human pregnancy is limited There are no published prospective evaluations of toxicities experienced by pregnant women on PI-containing antiretroviral regimens despite findings of metabolic disturbances of glucose fatty acids and cholesterol as well as lactic acidosishepatic steatosis in nonpregnant individuals treated with antiretrovirals Gastrointestinal GI side effects also are well documented in nonpregnant individuals treated with PIs but have not been systematically evaluated in pregnancy In addition the physiologic changes brought about by pregnancy may influence the pharmacokinetics safety and side effects of antiretroviral drugs There remains a need for further evaluation of the use of antiretrovirals during pregnancy and their impact on maternal fetal and infant safety
Patients are stratified according to whether or not they are on a PI-containing antiretroviral regimen and the number of weeks of gestation 26 weeks or less versus greater than 26 weeks Patients are followed at 8-week intervals from the time of entry until delivery or pregnancy termination with an additional visit at 12 weeks after delivery or pregnancy termination All infants born to study participants are evaluated at the time of delivery anthropometrics and HIV DNA PCR and are seen again at the mothers 12-week post-delivery visit Glucose tolerance testing and other metabolic studies are performed serially during pregnancy and again postpartum This is an observational study and drugs are not supplied Patients receiving antiretroviral therapy must obtain their own medications
Patients are stratified according to whether or not they are on a PI-containing antiretroviral regimen and the number of weeks of gestation 26 weeks or less versus greater than 26 weeks Patients are followed at 8-week intervals from the time of entry until delivery or pregnancy termination with an additional visit at 12 weeks after delivery or pregnancy termination All infants born to study participants are evaluated at the time of delivery anthropometrics and HIV DNA PCR and are seen again at the mothers 12-week post-delivery visit Glucose tolerance testing and other metabolic studies are performed serially during pregnancy and again postpartum This is an observational study and drugs are not supplied Patients receiving antiretroviral therapy must obtain their own medications
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 A5084 | None | None | None |