Antiviral Activity and Safety of Mifepristone at 2 Doses in HIV-1 Infected Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: VGX-410 (Mifepristone); Placebo for VGX-410 (Mifepristone)
Intervention MeSH terms: Mifepristone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV-1

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.
    

Eligibility 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