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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VGX Pharmaceuticals, LLC
• Treatments: Mifepristone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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