Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386230
Status:
COMPLETED
Last Update Posted:
2008-05-02
First Post:
2006-10-10
Brief Title:
Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
Short ZDV Course to Prevent Perinatal HIV in Thailand
Status:
COMPLETED
Status Verified Date:
2008-05
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 the study was to test the equivalence of a short zidovudine ZDV regimen as compared to a longer ACTG-076-like ZDV regimen in reducing the risk of mother-to-child transmission of HIV and to assess and compare the safety and tolerance of the long and shortened ZDV regimens
Detailed Description:
Multicenter randomized four arms double-blind controlled study Consenting pregnant women were tested for HIV from the beginning of pregnancy until 26 of gestational age GA If HIV-positive and eligible women completed a Pre-entry baseline check-up Enrollment took place at 28 weeks gestational age Women meeting selection criteria were randomly assigned to one of four study arms see below
AMENDMENT March 20 1999
Data Safety and Monitory Board interim review March 17 1999 The DSMB reported that the transmission rate in the longest arm long treatment of both mother and baby was significantly lower than that in the shortest arm short treatment of both the mother and the baby and this discrepancy was larger than the previously agreed on difference which if found would call for changing the study design In addition the transmission rates in the remaining two arms of the study were similar to that in the longest arm The difference that was found could not be explained by any baseline characteristics of the participants such as maternal age gestational age at delivery birth weight cesarean section rate or any others
The DSMB recommended that enrollment into the shortest arm of the study be terminated and the study be continued with a modification of design so that new enrollees would enter one of the three remaining arms
All women enrolled before this amendment was effective and delivering after March 20th 1999 and previously randomized to the Smother-Sinfant arm were unblinded in order to give their infants open label zidovudine for 6 weeks
AMENDMENT March 20 1999
Data Safety and Monitory Board interim review March 17 1999 The DSMB reported that the transmission rate in the longest arm long treatment of both mother and baby was significantly lower than that in the shortest arm short treatment of both the mother and the baby and this discrepancy was larger than the previously agreed on difference which if found would call for changing the study design In addition the transmission rates in the remaining two arms of the study were similar to that in the longest arm The difference that was found could not be explained by any baseline characteristics of the participants such as maternal age gestational age at delivery birth weight cesarean section rate or any others
The DSMB recommended that enrollment into the shortest arm of the study be terminated and the study be continued with a modification of design so that new enrollees would enter one of the three remaining arms
All women enrolled before this amendment was effective and delivering after March 20th 1999 and previously randomized to the Smother-Sinfant arm were unblinded in order to give their infants open label zidovudine for 6 weeks
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 |
|---|---|---|---|
| NIH 5 R01 HD33326-05 | None | None | None |