Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People (NCT00099645) | Clinical Trial Compass
CompletedPhase 1/2
Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People
United States48 participants
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in HIV-1 viral load from baseline to Days 14 and 28
Trial details
NCT IDNCT00099645
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)