Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021671
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-07-31
Brief Title:
Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
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:
The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby
A link between bacterial disease of the vagina premature birth infection of the uterus during pregnancy and the passing of HIV from a mother to her baby has been found Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby
Note As of 022103 enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission
A link between bacterial disease of the vagina premature birth infection of the uterus during pregnancy and the passing of HIV from a mother to her baby has been found Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby
Note As of 022103 enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission
Detailed Description:
Obstetric risk factors for HIV maternal-child transmission MCT include preterm birth prolonged rupture of the membranes and chorioamnionitis Many preterm births are associated with and likely caused by chorioamnionitis The relationship between bacterial vaginosis preterm birth histologic chorioamnionitis and perinatal transmission of HIV has been consistently demonstrated Perinatal HIV transmission is more common in preterm infants and there is now evidence that subclinical chorioamnionitis is a substantial risk factor for MCT For this study the primary hypothesis is that early and appropriate treatment of subclinical chorioamnionitis prior to the onset of spontaneous preterm labor andor antibiotic treatment during labor to prevent premature rupture of membrane-associated-chorioamnionitis will reduce the risk of perinatal HIV transmission
Note As of 022103 enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission
At 20 to 24 weeks women who are randomized to receive antibiotics receive metronidazole and erythromycin for 7 days Women randomized to the control group receive identically appearing placebos With the onset of contractions andor premature rupture of membranes study participants will initiate a second oral course of antibiotics consisting of metronidazole and ampicillin or placebo every 4 hours continuing after delivery until the course is completed All HIV-infected women and their neonates will be offered the HIVNET 012 nevirapine NVP regimen If the mother accepts the NVP for herself and her baby she will be given 1 dose of NVP to be taken at onset of labor and her baby will receive 1 dose of NVP at 72 hours post-birth or discharge whichever occurs earlier If the mother refuses NVP or is uninfected she will receive a matched placebo at the 26- to 30-week visit to preserve participant confidentiality This study takes place in Blantyre and Lilongwe Malawi in Lusaka Zambia and in Dar es Salaam Tanzania
Note As of 022103 enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission
At 20 to 24 weeks women who are randomized to receive antibiotics receive metronidazole and erythromycin for 7 days Women randomized to the control group receive identically appearing placebos With the onset of contractions andor premature rupture of membranes study participants will initiate a second oral course of antibiotics consisting of metronidazole and ampicillin or placebo every 4 hours continuing after delivery until the course is completed All HIV-infected women and their neonates will be offered the HIVNET 012 nevirapine NVP regimen If the mother accepts the NVP for herself and her baby she will be given 1 dose of NVP to be taken at onset of labor and her baby will receive 1 dose of NVP at 72 hours post-birth or discharge whichever occurs earlier If the mother refuses NVP or is uninfected she will receive a matched placebo at the 26- to 30-week visit to preserve participant confidentiality This study takes place in Blantyre and Lilongwe Malawi in Lusaka Zambia and in Dar es Salaam Tanzania
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 |
|---|---|---|---|
| 11622 | REGISTRY | DAIDS ES | None |