Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000869
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
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 giving the anti-HIV drug nevirapine NVP to HIV-positive pregnant women and their babies can help reduce the chance that a mother will give HIV to her baby during delivery This study will also test the safety of the drug and see how well it is tolerated by the mother and her baby
Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies
Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies
Detailed Description:
Nevirapine has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early postpartum period The pharmacokinetic profile suggested that nevirapine would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery In addition nevirapine has been shown to penetrate cell-free virions and inactivate virion-associated reverse transcriptase RT in situ This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk These characteristics of nevirapine suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of nevirapine may provide a prophylactic level of nevirapine in the infant during the time of exposure to virus in the birth canal andor maternal blood In addition nevirapine may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk
Women are randomized to receive either NVP or the corresponding placebo in active labor Women are randomized at any time after their 32nd week gestation AS PER AMENDMENT 11398 28th week gestation AS PER AMENDMENT 22300 20th week gestation The randomization is stratified using two factors 1 use of AS PER AMENDMENT 22300 current or anticipated antiretroviral therapy during the current pregnancy no therapy at all monotherapy for any duration multi-agent therapy for any duration and 2 CD4 cell count at the time of randomization less than 200 cells 200 - 399 cells 400 cells or greater Mothers are followed on study for 4 to 6 weeks postpartum Mothers are also encouraged to follow the regimen of zidovudine ZDV outlined in the Office of Public Health and Science PHS treatment guidelines for both themselves and their infants Infants are administered either NVP or placebo between 48 and 72 hours of life The infants study drug is the same as the mothers randomized treatment assignment Infants are dosed with the study drug according to their randomization group regardless of whether the mother received the study drug Infants are followed for 4 to 6 weeks and are tested for HIV at 4 to 6 weeks 3 months and 6 months
Women are randomized to receive either NVP or the corresponding placebo in active labor Women are randomized at any time after their 32nd week gestation AS PER AMENDMENT 11398 28th week gestation AS PER AMENDMENT 22300 20th week gestation The randomization is stratified using two factors 1 use of AS PER AMENDMENT 22300 current or anticipated antiretroviral therapy during the current pregnancy no therapy at all monotherapy for any duration multi-agent therapy for any duration and 2 CD4 cell count at the time of randomization less than 200 cells 200 - 399 cells 400 cells or greater Mothers are followed on study for 4 to 6 weeks postpartum Mothers are also encouraged to follow the regimen of zidovudine ZDV outlined in the Office of Public Health and Science PHS treatment guidelines for both themselves and their infants Infants are administered either NVP or placebo between 48 and 72 hours of life The infants study drug is the same as the mothers randomized treatment assignment Infants are dosed with the study drug according to their randomization group regardless of whether the mother received the study drug Infants are followed for 4 to 6 weeks and are tested for HIV at 4 to 6 weeks 3 months and 6 months
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 |
|---|---|---|---|
| 11290 | REGISTRY | DAIDS ES Registry Number | None |