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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 2

Phase 1

Conditions

HIV Infections

Treatments

Drug: Mifepristone

Study type

Interventional

Funder types

NIH

Identifiers

NCT00099645

10186 (Registry Identifier)

ACTG A5200

A5200

Details and patient eligibility

About

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.

Full description

Mifepristone is a potent anti-glucocorticoid compound that effectively inhibits replication of both laboratory and clinical HIV isolates in vitro. This study will evaluate the anti-HIV activity and safety of 3 different doses of mifepristone in HIV infected people.

This study will last approximately 2 months. Participants will be randomly assigned to one of 4 study arms, and will receive either mifepristone or placebo daily for 28 days. Arm A participants will receive one of three doses of placebo; Arm B participants will receive 75 mg mifepristone; Arm C participants will receive 150 mg mifepristone; and Arm D participants will receive 225 mg mifepristone. A thorough neck and thyroid examination will be performed within 30 days prior to study entry. Blood collection and vital signs measurement will occur at study entry and Days 3, 7, 14, 21, 28, and 56. Urine collection and pill counts will also be done at some study visits.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.