Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00162227
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2014-01-09
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Expanded Access Study of Oral Liquid Efavirenz in the Treatment of Children With HIV Infection
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
US Sustiva Oral Liquid Expanded Access Program: an Open-label, Multicenter Expanded Access Study of the Liquid Formulation of Sustiva (Efavirenz, DMP 266)
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to assess the safety and tolerability of an oral liquid solution of Sustiva for antiretroviral therapy-naive or therapy-experienced HIV-1 infected children between the ages 3-16 who are failing or intolerant of current antiretroviral regimen and who are unable to swallow Sustiva capsules.
Detailed Description:
None
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?: