Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People

Inclusion Criteria:

• HIV-1 infected
• CD4 count of 350 cells/mm3 or more within 90 days prior to study entry
• HIV-1 viral load of 2000 copies/ml or more within 90 days prior to study entry
• Willing to use acceptable forms of contraception during the study and for 30 days after stopping study medication
• If currently taking precautionary concomitant medications, must be on stable doses for more than 8 weeks prior to study entry and have no plans to change medications or doses for the duration of the study
• Body weight at least 40 kg (88 lbs) within 90 days prior to study entry

Exclusion Criteria:

• Antiretroviral treatment (ART) within 16 weeks prior to study entry, or intend to start ART within 60 days after entry
• Adrenal disorders
• History of autoimmune endocrine disease in self or family
• History of active hepatitis B or C
• Current treatment for hepatitis B or C
• Moderate to severe liver disease
• Blood disorders or current anticoagulant therapy
• Prior pituitary tumor, surgery, radiation treatment, or pituitary failure
• Moderate to large goiters or thyroid nodules
• Diabetes mellitus
• Unusual uterine bleeding within 12 months prior to study entry
• Current hormonal contraception or intrauterine (IUD) use, including progesterone-containing vaginal rings
• Pregnancy within 90 days prior to study entry
• Breast-feeding
• Drugs that act as inhibitors or inducers of metabolism by cytochrome P450 3A4
• Systemic corticosteroids or hormonal agents within 90 days prior to study entry
• Any immunomodulator, HIV vaccine, or investigational therapy within 90 days prior to study entry
• Any vaccination within 30 days prior to study entry
• Systemic cytotoxic chemotherapy within 90 days prior to study entry
• History of allergy to mifepristone or the study formulations
• Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
• Any other conditions that may interfere with participant evaluation during the study
• Serious illness requiring systemic treatment or hospitalization. Patients who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.