Status:
COMPLETED
Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
Lead Sponsor:
VGX Pharmaceuticals, LLC
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 30...
Eligibility Criteria
Inclusion
- HIV-1 infection
- CD4 cell count \> 200
- Plasma HIV-1 RNA \> 2000 copies/mL and have not received antiretroviral therapy within the 16 weeks prior to entry
- Absolute neutrophil count \> 750/mm3
- Hemoglobin \> 10 g/dL
- Platelet count \> 100,000 mm3
- Creatinine \< 2 X upper limit of normal \[ULN\] (fasting)
- AST (SGOT), ALT (SGPT), and alkaline phosphatase \< 2 X ULN
- Total bilirubin \< 2.5 X ULN
- Albumin \> 3 g/dL
- Serum lipase \< 1.5 X ULN
- Thyroid stimulating hormone (TSH) within normal limits
- Plasma cortisol \> 20 mcg/dL, 30 minutes after cosyntropin administration
- Negative pregnancy test and willing to use effective birth control during the study
- Karnofsky performance score \> 80 within 30 days prior to study entry
- Men and women \>= 18 years of age
Exclusion
- Receipt of antiretroviral treatment within the 16 weeks prior to study entry
- Chronic adrenal failure, adrenal insufficiency, personal or family history of autoimmune endocrine disease, history of active hepatitis B or C, or current treatment for hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Presence of diabetes mellitus
- Pregnancy within 90 days prior to study entry or breast-feeding
- Dysfunctional uterine bleeding within the 12 months prior to study entry
- Any current hormonal contraception or intrauterine device (IUD) use
- Use of drugs that are inhibitors or inducers of metabolism by the cytochrome P450 3A4 within 7 days prior to study entry
- Use of systemic corticosteroids or hormonal agents within 90 days prior to study entry
- Use of any immunomodulator, HIV vaccines, or investigational therapy within 90 days prior to study entry
- Any vaccination within 30 days prior to study entry
- Use of systemic cytotoxic chemotherapy within 90 days prior to study entry
- History of allergy to mifepristone or its formulations
- Active drug or alcohol use
- Serious illness requiring systemic treatment and/or hospitalization for at least 14 days prior to study entry
- Weight \< 40 kg or 88 lbs. within 90 days prior to study entry
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00352911
Start Date
July 1 2006
End Date
November 1 2007
Last Update
March 9 2010
Active Locations (3)
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1
Georgetown University
Washington D.C., District of Columbia, United States, 20007
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Veterans Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104