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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the anti-HIV activity and safety of 3 different doses of mifepristone (also known as VGX-410 and RU486) in HIV infected people.

Hypothesis: Mifepristone will be generally safe (no serious adverse effects) and well tolerated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Mifepristone

Criteria

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.