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Should HIV treatment start right away? new study tests timing

NCT ID NCT03825523

Disease control Sponsor: Gustavo Reyes-Teran Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This study looked at whether starting antiretroviral therapy (ART) immediately (within 48 hours) versus waiting until an opportunistic infection is under control affects death rates in HIV/AIDS patients hospitalized with such infections. Researchers enrolled 114 adults with HIV and an opportunistic disease. The goal was to see if immediate treatment saves more lives.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antiretroviral therapy (ART)
What this could lead to
If immediate ART works better, it could lead to a standard practice of starting HIV treatment right away in hospitalized patients with opportunistic infections, potentially saving more lives.
What could go wrong
This is a small completed study (114 participants) and results may not apply to all HIV patients, especially those with certain infections like cryptococcal meningitis. Timing of ART is just one factor in a complex disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

114 people

The number who actually took part.

Started

Jan 2018

Finished

Aug 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease HIV-associated cancer opportunistic infectious

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antiretroviral treatment HIV/AIDS

Contacts and locations

Locations

  • Centro de Investigacion en Enfermedades Infecciosas

    México, State of Mexico, 14080, Mexico

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