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HIV breakthrough trial seeks to rescue failing treatments in africa

NCT ID NCT05373758

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests different approaches to help people with HIV whose current medication (tenofovir, lamivudine, and dolutegravir, or TLD) is no longer working. It involves 648 adults and teens in Uganda and South Africa. The goal is to find the best strategy to get the virus under control again, measured by a very low viral load after 48 weeks.

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 648 people

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

Started

Feb 2024

Expected to finish

Jun 2027

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

15 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: * Age 15 years and above * Enrolled in HIV care at one of the study clinics * History of two HIV-1 RNA viral load measurements \>1,000 copies/mL while on TLD * On TLD for at least 12 months * Lives within 100 kilometers of study clinic * Pregnant women are eligible for enrollment. Exclusion Criteria: * Plans to transfer out of the clinic within the next 48 weeks * Plans to move out of the study catchment area within the next 48 weeks * As determined by chart review, we will exclude those with known virologic failure on protease inhibitors or exposure to integrase strand transfer inhibitors other than dolutegravir.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease Medication Adherence

As listed by the trial registrant

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

AIDS HIV infections Virologic failure

How to take part

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

  1. The places running it

    3 sites in 2 countries. 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

  • Mbarara City Clinic

    RECRUITING

    Mbarara, Uganda

  • Mbarara Regional Referral Hospital Immune Suppression Syndrome Clinic

    RECRUITING

    Mbarara, Uganda

  • RK Khan Hospital Clinic

    RECRUITING

    Durban, South Africa

More trials for these conditions

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