CompletedPhase 4

Cryptococcal Optimal ART Timing Trial

South Africa, Uganda177 participantsStarted 2010-11

Plain-language summary

The Cryptococcal Optimal ART Timing (COAT) trial seeks to determine after cryptococcal meningitis (CM) whether early initiation of antiretroviral therapy (ART) prior to hospital discharge results in superior survival compared to standard initiation of ART started as an outpatient.

Who can participate

Age range

14 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-infection, documented by ELISA * Antiretroviral medication naïve (excluding mother-to-child transmission therapy) * Age \>14 years * Cryptococcal meningitis diagnosed by either culture or CSF cryptococcal antigen (CRAG) * Ability and willingness of the participant or legal guardian/representative to give informed consent. * Receiving amphotericin-based anti-fungal therapy Exclusion Criteria: * Study entry prior to receipt of \<7 days or \>11 days of amphotericin therapy * History of prior, known cryptococcal meningitis * Inability to take enteral medication * Receiving chemotherapy or other immunosuppressant medications * Cannot or unlikely to attend regular clinic visits * Contraindication to immediate or delayed HIV therapy based on serious co-morbidities or co-infections, or laboratory values * Pregnancy or Breastfeeding * Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception

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

Mortality

Timeframe: 26 weeks from study entry

Trial details

NCT IDNCT01075152

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2014-06-27

View on ClinicalTrials.gov More Cryptococcal Meningitis trials

Who can participate

Age range

14 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.