Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352911
Status:
COMPLETED
Last Update Posted:
2010-03-09
First Post:
2006-07-13
Brief Title:
Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
Sponsor:
VGX Pharmaceuticals LLC
Organization:
VGX Pharmaceuticals LLC
Study Overview
Official Title:
A Randomized Placebo-controlled Dose Escalating Phase II Trial of the Anti -HIV-Activity and Safety of VGX-410 Mifepristone in HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2010-03
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:
The objective of the study is to determine whether mifepristone VGX-410 has anti-HIV-1 activity at doses of either 300 mg or 600 mg per day after oral administration for 14 days at each dose level
Detailed Description:
VT004 is a double-blind randomized placebo-controlled Phase II study of two doses of orally administered mifepristone VGX-410 300 and 600 mg taken as a twice daily BID dosage 150mg BID and 300mg BID in a dose-escalating fashion for 14 days at each dose level to determine antiviral activity and safety in HIV-1-infected participants At entry 18 subjects will be randomized in a 51 fashion 15 on active drug 3 on placebo to receive escalating doses of VGX-410 or matching placebo Patients will be randomized to receive 300 mg as 150 mg BID dose of VGX-410 or matching placebo for 14 days In patients that complete this dose without significant safety concerns or side effects the dose will be increased to 600 mg as 300 mg BID dose or matching placebo for 14 days Patients must meet all inclusionexclusion criteria listed below and be seen on a weekly basis by study personnel while on study drug Patients must return one month after finishing the study therapy for examination and safety labs
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