Ignite Creation Date:
2024-05-05 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00708110
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2008-06-30
Brief Title:
Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected Adults
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Phase 2a Multicenter Randomized Parallel Double-Blind Dose Ranging Placebo-Controlled Study to Compare Antiviral Effect Safety Tolerability and Pharmacokinetics of GSK1349572 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults ING111521
Status:
COMPLETED
Status Verified Date:
2013-08
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:
GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection This phase IIa multicenter randomized parallel double-blind dose ranging placebo-controlled proof of concept study is to be conducted to compare antiviral effect safety tolerability and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10 days in ART-naïve and experienced but integrase inhibitor naïve meaning never having had an integrase inhibitor HIV-1 infected adults who are not currently receiving antiretroviral therapy This study consists of a screening visit a treatment period and a follow-up evaluation Thirty subjects will be randomized to receive one of three doses of GSK1349572 or placebo q24h over 10 days Antiviral effect measures include viral load and CD4 cell count
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