Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006396
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2000-10-10
Brief Title:
Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns
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 Placebo-Controlled Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates
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 nevirapine NVP or zidovudine AZT given to mothers during labor and delivery and to their babies during the first week of life can reduce the rate of mothers passing HIV to their babies
About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and delivery There is an urgent need to find a simpler way to prevent mother-to-infant transmission during labor and delivery The proposed NVP schedule is simpler and possibly could be used in Uganda
About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and delivery There is an urgent need to find a simpler way to prevent mother-to-infant transmission during labor and delivery The proposed NVP schedule is simpler and possibly could be used in Uganda
Detailed Description:
There is an urgent need to find a safe effective means of preventing mother-to-infant HIV transmission that would also be applicable and affordable in developing-country settings The frequency of vertical HIV-1 transmission is estimated to be 25 percent The proposed trial specifically will test the hypothesis that chemoprophylaxis of the fetusneonate during labor and delivery and the first week of life may significantly reduce the risk of perinatal HIV-1 transmission
Pregnant women infected with HIV-1 are randomized to 1 of 4 study arms and receive either NVP or its placebo or AZT or its placebo Mothers in the NVP group receive a single dose of NVP or placebo at the onset of labor and are followed to 6 to 8 weeks after delivery Infants born to these mothers receive at 48 to 72 hours post-delivery or discharge whichever comes first a regimen of the same treatment NVP or placebo given to the mother Infants are followed for 18 months post-delivery by clinical and laboratory evaluation to determine toxicity evidence of HIV-1 infection and clinical disease progression
Mothers in the AZT group receive either a bolus of AZT or its placebo at onset of labor then doses every 3 hours until delivery with follow-up to 6 to 8 weeks Infants begin receiving either a lower dose of AZT or placebo as soon as they can tolerate liquids by mouth twice daily for 7 days and are followed for 18 months as in the NVP group
Pregnant women infected with HIV-1 are randomized to 1 of 4 study arms and receive either NVP or its placebo or AZT or its placebo Mothers in the NVP group receive a single dose of NVP or placebo at the onset of labor and are followed to 6 to 8 weeks after delivery Infants born to these mothers receive at 48 to 72 hours post-delivery or discharge whichever comes first a regimen of the same treatment NVP or placebo given to the mother Infants are followed for 18 months post-delivery by clinical and laboratory evaluation to determine toxicity evidence of HIV-1 infection and clinical disease progression
Mothers in the AZT group receive either a bolus of AZT or its placebo at onset of labor then doses every 3 hours until delivery with follow-up to 6 to 8 weeks Infants begin receiving either a lower dose of AZT or placebo as soon as they can tolerate liquids by mouth twice daily for 7 days and are followed for 18 months as in the NVP group
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 |
|---|---|---|---|
| 11719 | REGISTRY | DAIDS ES | None |