Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000942
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of Nevirapine to Prevent 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 Double-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
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:
NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early post-partum period The pharmacokinetic profile suggests that NVP would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration In addition NVP has been shown to penetrate cell-free virions and inactivate virion-associated 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 NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal andor maternal blood In addition NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk
Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo Randomization occurs at any time after the 28th week of gestation To assure balance between the treatment groups the randomization is stratified using 2 factors 1 use of antiretroviral therapy during the current pregnancy no antiretroviral therapy at all monotherapy with no multi-agent therapy for any duration multi-agent therapy for any duration and 2 CD4 cell count at the time of randomization less than 200 cells 200 to 399 cells 400 cells or greater Mothers are followed on-study for 4 to 6 weeks postpartum
Due to the results of ACTG 076 and 185 all women for entry into ACTG 316 are encouraged to incorporate a regimen of zidovudine ZDV into their current treatment regimen and should continue ZDV during delivery and to their neonates for at least 6 weeks post-birth
Infants receive a single oral dose of NVP or the corresponding placebo administered between 48 and 72 hours of life The infants study drug is the same as the mothers randomized treatment assignment Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not Infants are followed for 6 months of life and are tested for HIV at birth 4 to 6 weeks of life 3 months of life and 6 months of life
Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo Randomization occurs at any time after the 28th week of gestation To assure balance between the treatment groups the randomization is stratified using 2 factors 1 use of antiretroviral therapy during the current pregnancy no antiretroviral therapy at all monotherapy with no multi-agent therapy for any duration multi-agent therapy for any duration and 2 CD4 cell count at the time of randomization less than 200 cells 200 to 399 cells 400 cells or greater Mothers are followed on-study for 4 to 6 weeks postpartum
Due to the results of ACTG 076 and 185 all women for entry into ACTG 316 are encouraged to incorporate a regimen of zidovudine ZDV into their current treatment regimen and should continue ZDV during delivery and to their neonates for at least 6 weeks post-birth
Infants receive a single oral dose of NVP or the corresponding placebo administered between 48 and 72 hours of life The infants study drug is the same as the mothers randomized treatment assignment Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not Infants are followed for 6 months of life and are tested for HIV at birth 4 to 6 weeks of life 3 months of life and 6 months of life
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 |
|---|---|---|---|
| 11291 | REGISTRY | DAIDS ES Registry Number | None |