Trial Outcomes & Findings for Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects (NCT NCT00352911)

Last Updated: 2010-03-09

Results Overview

Mean log change in HIV RNA viral load (significant reduction is considered \>0.5 log 10) from baseline (Day 1) to Day 56 following 150mg twice daily for 14 days, dose escalation to 300mg twice daily for 14 days and then 28 days off treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Baseline (Day 1) to Day 56

Results posted on

2010-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	VGX-410 (Mifepristone) 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days	Placebo for VGX-410 (Mifepristone) 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
150mg Twice Daily (14 Days) STARTED	16	3
150mg Twice Daily (14 Days) COMPLETED	16	3
150mg Twice Daily (14 Days) NOT COMPLETED	0	0
300mg Twice Daily (14 Days) STARTED	16	3
300mg Twice Daily (14 Days) COMPLETED	15	3
300mg Twice Daily (14 Days) NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VGX-410 (Mifepristone) n=16 Participants 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days	Placebo for VGX-410 (Mifepristone) n=3 Participants 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days	Total n=19 Participants Total of all reporting groups
Age Continuous	42.3 years STANDARD_DEVIATION 8.0 • n=93 Participants	37.7 years STANDARD_DEVIATION 7.4 • n=4 Participants	41.6 years STANDARD_DEVIATION 7.9 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	3 Participants n=4 Participants	17 Participants n=27 Participants
Region of Enrollment United States	16 participants n=93 Participants	3 participants n=4 Participants	19 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 56

Outcome measures

Outcome measures
Measure	VGX-410 (Mifepristone) n=16 Participants 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days	Placebo for VGX-410 (Mifepristone) n=3 Participants 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
Mean Log Change in Viral Load From Baseline (Day 1) to Day 56	0.18 copies/mL on log scale Standard Deviation 0.28	0.42 copies/mL on log scale Standard Deviation 0.39

Adverse Events

VGX-410 (Mifepristone)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo for VGX-410 (Mifepristone)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VGX-410 (Mifepristone) n=16 participants at risk 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days	Placebo for VGX-410 (Mifepristone) n=3 participants at risk 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
General disorders Pyrexia	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.

Other adverse events

Additional Information

Mary Giffear, Sr. Clinical Scientist

VGX Pharmaceuticals, LLC

Phone: 267 440 4220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	VGX-410 (Mifepristone) n=16 participants at risk 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days	Placebo for VGX-410 (Mifepristone) n=3 participants at risk 150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
Nervous system disorders Headache	18.8% 3/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	33.3% 1/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Psychiatric disorders Libido Increased	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Psychiatric disorders Stress	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Reproductive system and breast disorders Metrorrhagia	12.5% 2/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Skin and subcutaneous tissue disorders Pruritis	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	33.3% 1/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Skin and subcutaneous tissue disorders Rash Papular	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorders	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	33.3% 1/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Vascular disorders Hot Flush	12.5% 2/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Vascular disorders Hypertension	18.8% 3/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Blood and lymphatic system disorders Eosinophilia	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Gastrointestinal disorders Gastrointestinal Disorders	18.8% 3/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Gastrointestinal disorders Abdominal Pain	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Gastrointestinal disorders Constipation	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Gastrointestinal disorders Diarrhoea	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Gastrointestinal disorders Nausea	12.5% 2/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Gastrointestinal disorders Odynophagia	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Gastrointestinal disorders Vomiting	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
General disorders Pain	0.00% 0/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	33.3% 1/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Immune system disorders Food Allergy	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Infections and infestations Nasopharyngitis	0.00% 0/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	33.3% 1/3 • AEs that occurred during the treatment period (Days 1-28) of the study.
Metabolism and nutrition disorders Hypokalaemia	6.2% 1/16 • AEs that occurred during the treatment period (Days 1-28) of the study.	0.00% 0/3 • AEs that occurred during the treatment period (Days 1-28) of the study.