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Personalized HIV dosing: genetic and drug monitoring trial aims to reduce side effects

NCT ID NCT03385473

Knowledge-focused Sponsor: Hospital Italiano de Buenos Aires 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This completed study tested whether using genetic information and measuring drug levels in the blood can help doctors choose the right dose of HIV medications (efavirenz or atazanavir) for each patient. 190 adults starting HIV treatment for the first time took part across four sites in Buenos Aires. The goal was to see if this personalized approach could reduce side effects and improve treatment success compared to standard dosing.

What this could mean

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

What this could lead to
If successful, this could show that personalized dosing based on genetics and drug levels makes HIV therapy safer and more effective.
What could go wrong
This is a small, early-stage feasibility study, not a large trial. The approach may not prove better than standard care or may be too complex for routine use.

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

190 people

The number who actually took part.

Started

Oct 2017

Finished

Dec 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Adult patients with diagnosis of chronic HIV infection confirmed by Western blot and / or HIV viral load * Patients in whom (according to the judgment of the treating physician) antiretroviral therapy should be initiated and this treatment will be a regimen based on Efavirenz or Atazanavir. * Availability of a baseline genotyping test confirming the absence of primary resistance for the selected drugs. * Signature of the informed Consent Form Exclusion Criteria: * Patients who remain untreated or those treated with a regimen that does not include efavirenz or atazanavir * Lack of understanding of the study characteristics or rejection to have samples taken for the pharmacological studies. * Patients who are not expected to continue their follow-up at the research center for at least one year * Patients with coinfections or comorbidities that prevent a dose adjustment of efavirenz or atazanavir based on pharmacological parameters.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

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

Drug monitoring HIV Pharmacogenetics

Contacts and locations

Locations

  • Hospital Italiano de Buenos Aires - Infectious Diseases Section

    Buenos Aires, Buenos Aires F.D., 1181, Argentina

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