CompletedNot Applicable

Immediate ART in Subjects With Opportunistic Diseases

Mexico114 participantsStarted 2018-01-29

Plain-language summary

The aim of this study is to compare the clinical response and mortality rate due to opportunistic disease in HIV-infected individuals who start immediate versus conventional antiretroviral therapy (ART). Immediate ART (iART) is defined as starting antiretroviral therapy within the first 48 hours after hospitalization. Conventional ART (cART) is defined as starting antiretroviral therapy once the opportunistic infection is under control at the discretion of the infectious disease specialist.

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 infection documented by ELISA or rapid test. * Age 18 years or older. * Hospitalized at the emergency department, intensive care unit, or clinical pulmonology ward of the National Institute of Respiratory Diseases (INER) with clinical criteria of an opportunistic infection or AIDS-related malignancy. * Candidate to initiate first ART regimen or presenting with first- or second-line ART failure. * ART-naïve or with ART discontinuation for at least 3 months prior to enrollment. Exclusion Criteria: * Diagnosis or clinical symptoms suggestive of cryptococcal meningitis, tuberculous meningitis, or meningitis of any other cause. * Pregnant women. * Admitted exclusively for treatment of neurosyphilis without any other active opportunistic infection.

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 at 30 days.

Timeframe: 30 days from ART initiation

Trial details

NCT IDNCT03825523

SponsorGustavo Reyes-Teran

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-08-05

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