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Could a Two-Drug HIV pill work for TB patients?

NCT ID NCT06497465

Disease control Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a two-drug HIV regimen (dolutegravir plus lamivudine) works as well as the standard three-drug regimen in people who also have tuberculosis and are on TB treatment. About 150 participants who have never taken HIV medication will be randomly assigned to one of three groups. The goal is to see if the simpler regimen can control HIV just as effectively while reducing the number of pills and potential side effects.

What this could mean

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

Active substance
Dolutegravir and lamivudine (DTG/3TC)
What this could lead to
If successful, this could offer a simpler, lower-toxicity HIV treatment option for people also being treated for tuberculosis.
What could go wrong
This is a mid-stage trial with only 150 participants. The dual therapy may not suppress HIV as well as the standard three-drug regimen, and drug interactions with TB meds remain a concern.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

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

Started

Sep 2025

Expected to finish

Jan 2029

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 to 99 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: * Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of \>1,000 copies/mL are also acceptable as documentation of HIV-1 infection. * CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry * HIV-1 viral load ≥1000 copies/mL * ART-naïve. * Documentation of pulmonary TB Exclusion Criteria: * Pregnant, or plans to become pregnant.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease pulmonary tuberculosis tuberculosis

As listed by the trial registrant

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

HIV Tuberculosis

How to take part

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

  1. The places running it

    6 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

  • CePClin - Center for Studies and Research in Infectious Diseases Ltda

    RECRUITING

    Natal, Rio Grande do Norte, 59.025-050, Brazil

  • FIOCruz

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

  • Hospital Geral de Nova Iguaçu

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 26210-190, Brazil

  • Instituto Tropical de Doenças Infecciosas Manaus

    RECRUITING

    Manaus, Amazonas, 69040-000, Brazil

  • RDSS- Ricardo Diaz Solucoes Cientificas

    RECRUITING

    São Paulo, São Paulo, 04037-030, Brazil

  • Universidade Federal da Bahia

    RECRUITING

    Salvador, Estado de Bahia, 40110-160, Brazil

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