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Old HIV drug repurposed to flush out hidden virus in new pilot trial

NCT ID NCT06823596

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether adding the HIV drug efavirenz to a person's current antiretroviral therapy (ART) can kill cells that harbor hidden HIV. About 26 adults with HIV who have low but detectable virus levels despite good adherence will take efavirenz for 8 weeks. The goal is to see if this approach can reduce or eliminate that residual viremia.

What this could mean

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

Active substance
Efavirenz (an HIV drug also known as Sustiva)
What this could lead to
If it works, this could point toward a way to reduce the hidden HIV reservoir and lower persistent viremia, potentially improving long-term health.
What could go wrong
This is a very small, early pilot study with only 26 participants. The effect may be modest or not work at all, and efavirenz can cause side effects like dizziness or sleep problems.

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

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

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 to 89 years

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 for participants are: * Ability to provide signed written informed consent; age \>18 years * Documented HIV diagnosis * Continuous antiretroviral therapy for \> 4 years with no issues of adherence * Taking a stable ART regimen, without the inclusion of a protease inhibitor * At least 4 HIV viral loads \>20 and \< 400 copies/ml over the past two years * No documented resistance to EFV in history, no PI including ritonavir in current ART regimen or during study period * No evidence of EFV resistance by plasma virus sequencing at screening visit * Non-pregnant throughout the study period, if female sex * Good general health as shown by medical history and screening laboratory tests at the screening visit: * Hemoglobin ≥ 85 g/L, white blood cell count (WBC) \> 3,000 cells/mm3 * Total lymphocyte count .750 X109/L * Platelets = 50 to 550 X109/L * Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase \< 5 times the institutional upper limit of normal (ULN); * Willing to undergo either leukapheresis or blood draw at visits 2 and 7 (participants will be given the option to undergo blood draws rather than leukapheresis) * Ability to add efavirenz to their current ART HIV medication re: avoid drug to drug interactions Exclusion criteria There will be no exclusion criteria based on gender/gender identity, ethnoracial composition, language, socioeconomic status, mode of HIV acquisition or sexual orientation/identity. Any participant who requires language interpretation can and will be accommodated for by the participation of translators, either at the patient's choice and/or with the assistance of the translator services provided by local ASO organizations. Exclusion criteria for participants include the following: * Participants who would have difficulty participating in a trial due to non-compliance * No active medications / illicit drugs that could adversely affect study compliance * Currently prescribed and using EFV as part of ongoing ART treatment regimen for HIV suppression * Currently prescribed a protease inhibitor or pharmacologic booster (cobisistat) as part of current ART regimen * History of major psychiatric condition that would be adversely affected by efavirenz * Diagnosed severe cognitive impairment or of strong concern in the judgement of investigators that efavirenz would adversely affect participant * Documented or suspected history of resistance to any NNRTI including efavirenz, nevirapine or rilpivirine * History of severe intolerance or documented allergy to efavirenz * Participants with any of the following abnormal laboratory results at the screening visit: * Hemoglobin \< 85 g/L * Lymphocyte count \< .750 X109/L * Platelet count \< 50 X109/L or \> 550 X109/L * AST or ALT \> 5X the upper limit of normal * Creatinine \> 250 µmol/L * Participants with a malignancy or undergoing chemotherapy * Participants with other significant underlying disease (non-HIV-1) that might impinge upon disease progression or death * Any concurrent condition requiring the continued use of immunoglobulin, antineoplastic agents, glucocorticoids (other than corticosteroid nasal spray for allergic rhinitis; topical or ophthalmic corticosteroids for acute, uncomplicated dermatitis or conjunctivitis; over the counter medications for acute, uncomplicated dermatitis for treatment period not longer than 14 days) or other immunomodulator medications (other than NSAIDS which will be allowed for any length of time) * Active drug or alcohol use/dependence that, in the opinion of the investigator, would interfere with adherence to study requirements * Any illness or conditions including acute illnesses that, in the opinion of the investigator, may affect the safety of the participant or the evaluation of any study endpoints * Any other conditions judged by the investigator that would limit the evaluation of a participant * Any confirmed or suspected immunosuppressive or immunodeficient state (except HIV infection for Group-3), asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past six months (topical steroids are allowed)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Maple Leaf Medical Clinic

    RECRUITING

    Toronto, Ontario, M5G 1K2, Canada

  • Unity Health Toronto -St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

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