NCT00352911

Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: VGX Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 5:1 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 inclusion/exclusion 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	VGX-410 (Mifepristone)
DRUG	Placebo for VGX-410 (Mifepristone)

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-06-01
• Completion: 2007-11-01
• First posted: 2006-07-17
• Last updated: 2010-03-09
• Results posted: 2010-01-27

Locations

3 sites across 1 country: United States