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

Completed · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00352911

Run by

VGX Pharmaceuticals, LLC

People needed

19

Starts

2006-07-01

Expected to finish

2007-11-01

Last updated by the study team

2010-03-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgetown University — Washington D.C., District of Columbia, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Veterans Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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