Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022763
Status:
COMPLETED
Last Update Posted:
2016-02-15
First Post:
2001-08-11
Brief Title:
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2016-01
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 will evaluate T-20 in children
Detailed Description:
Children are stratified by age group 3 through 11 years and 12 through 16 years Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals Simultaneous to initiating T-20 all patients begin a new optimized antiretroviral regimen based on the patients prior treatment history historical resistance testing results and the results of the testing performed at screening Patients are followed for safety and other assessments at Weeks 1 2 and 4 then monthly through Week 24 and bimonthly through Week 48 Pharmacokinetic sampling at selected study visits are performed
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 295E | None | None | None |
| T20-310 | None | None | None |