Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-04-16 @ 9:55 PM
Study NCT ID:
NCT02613169
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2015-09-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Infant TB Infection Prevention Study
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants
Status:
COMPLETED
Status Verified Date:
2023-03
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:
iTIPS
Brief Summary:
Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.
Detailed Description:
The purpose of this trial is to determine whether isoniazid (INH) reduces the risk of Mycobacterium tuberculosis (MTB) infection in HIV-exposed but uninfected (HEU) children, as well as to determine epidemiologic and immunologic correlates of MTB infection in HEU.
Study Oversight
Has Oversight DMC:
True
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?: