Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340080
Status:
COMPLETED
Last Update Posted:
2010-01-25
First Post:
2006-06-19
Brief Title:
Clinical Utility Of Genetic Screening For HLA-B5701 On Susceptibility To Abacavir Hypersensitivity
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase IV Randomised Multicentre Double-blind Study to Evaluate the Clinical Utility of Prospective Genetic Screening HLA-B5701 for Susceptibility to Abacavir Hypersensitivity
Status:
COMPLETED
Status Verified Date:
2010-01
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:
Study to evaluate the utility of prospective HLA-B5701 screening on the incidence of abacavir hypersensitivity ABC HSR in 1800 previously ABC-naive adults with HIV-1 from Europe Australia and other countries as applicable The study has two co-primary objectives i to determine if screening for HLA-B5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care no genetic screening and ii to determine if screening for HLA-B5701 prior to ABC-containing HAART results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care no genetic screening or patch testing The study consists of up to a 28-day screening period a randomised observation period Day 1 through Week 6 and for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects an epicutaneous patch test EPT assessment period Eligible subjects will be randomised to one of two study arms a Current Standard of Care Arm no prospective genetic screening Control and a Genetic Screening Arm prospective genetic screening Subjects identified as HLA-B5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later
Detailed Description:
None
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 |
|---|---|---|---|
| PREDICT-1 | None | None | None |