Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000862
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Study of Zidovudine During Labor and Delivery 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:
A Phase I Trial of the Pharmacokinetics and Tolerance of Oral Zidovudine Administered to HIV-1 Infected Pregnant Women During Labor and Delivery
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 obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine ZDV during labor and delivery will provide a similar profile to that obtained with the use of IV ZDV in ACTG 082 To evaluate the tolerance of oral ZDV in this population defined as the ability to take oral doses and lack of vomiting within 30 minutes of receiving oral study doses
The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible Approximately 18 of the women in the ACTG 076 trial missed their IV ZDV infusions even at experienced ACTG sites There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that at minimum will approximate the rate of ZDV administration utilized in ACTG 082 In the future this would enable women to start an intensive ZDV regimen during early labor even prior to reaching the hospital
The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible Approximately 18 of the women in the ACTG 076 trial missed their IV ZDV infusions even at experienced ACTG sites There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that at minimum will approximate the rate of ZDV administration utilized in ACTG 082 In the future this would enable women to start an intensive ZDV regimen during early labor even prior to reaching the hospital
Detailed Description:
The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible Approximately 18 of the women in the ACTG 076 trial missed their IV ZDV infusions even at experienced ACTG sites There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that at minimum will approximate the rate of ZDV administration utilized in ACTG 082 In the future this would enable women to start an intensive ZDV regimen during early labor even prior to reaching the hospital
Cohort 1 Women in active labor receive 3 doses of oral ZDV 3 hours apart followed by PK sampling After PK sampling post 3rd oral dose or at 8 cm dilation whichever comes first women receive IV ZDV until delivery The cord blood will be analyzed for serum ZDV PK levels and the infants infection status will be determined If the dose of ZDV is adequate to achieve targeted maternal serum drug levels in Cohort 1 and if oral dosing is tolerated in this cohort Cohort 2 will begin enrollment AS PER AMENDMENT 080301 Cohort 1 has been completed and only Cohort 2 is open for enrollment Cohort 2 AS PER AMENDMENT 080301 Women in active labor receive initial loading dose of oral ZDV then another dose of oral ZDV 3 hours later both doses followed by PK sampling After PK sampling post second oral dose or at 8 cm dilation whichever comes first woman receives IV ZDV until delivery The cord blood will not be analyzed for serum ZDV PK levels and the infants infection status will be determined
Cohort 1 Women in active labor receive 3 doses of oral ZDV 3 hours apart followed by PK sampling After PK sampling post 3rd oral dose or at 8 cm dilation whichever comes first women receive IV ZDV until delivery The cord blood will be analyzed for serum ZDV PK levels and the infants infection status will be determined If the dose of ZDV is adequate to achieve targeted maternal serum drug levels in Cohort 1 and if oral dosing is tolerated in this cohort Cohort 2 will begin enrollment AS PER AMENDMENT 080301 Cohort 1 has been completed and only Cohort 2 is open for enrollment Cohort 2 AS PER AMENDMENT 080301 Women in active labor receive initial loading dose of oral ZDV then another dose of oral ZDV 3 hours later both doses followed by PK sampling After PK sampling post second oral dose or at 8 cm dilation whichever comes first woman receives IV ZDV until delivery The cord blood will not be analyzed for serum ZDV PK levels and the infants infection status will be determined
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PACTG 324 | Registry Identifier | DAIDS ES Registry Number | None |
| 11298 | REGISTRY | None | None |