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Can a two-drug combo beat the HTLV-1 virus?

NCT ID NCT07555431

Disease control Sponsor: Carlos Brites 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial compares the drug dolutegravir alone versus dolutegravir combined with tenofovir in 146 adults with HTLV-1 infection and related symptoms. The main goal is to see if the combination lowers the virus level more effectively and improves pain, spasticity, and muscle strength over 48 weeks.

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 tenofovir disoproxil fumarate
What this could lead to
If successful, this could point toward a more effective treatment to lower the virus and ease symptoms like pain and muscle weakness in people with HTLV-1.
What could go wrong
This is a small, early-phase trial (Phase 2) with only 146 participants. The combination has not been tested before, so it may not work better than dolutegravir alone, and side effects are not yet well understood.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 146 people

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

Started

May 2026

Expected to finish

Jun 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 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 equal or higher than 18 years * Confirmed HTLV-1 infection * Clinical manifestation atributable to HTLV-1 * Ability to provide written informed consent Exclusion Criteria: * Active HIV, HCV (RNA+), or HBV (HBsAg+) infection * Active tuberculosis * Recent corticosteroid use * Renal impairment (CrCl \<50 mL/min) * Autoimmune diseases * Wheelchair-bound individuals * Active malignancy (except ATLL) * Substance abuse interfering with adherence * Any condition compromising safety

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Conditions

The condition(s) this trial relates to.

adult T-cell leukemia/lymphoma human T-lymphotropic virus 1 infectious disease Leukemia-Lymphoma, Adult T-Cell neuritis tropical spastic paraparesis

As listed by the trial registrant

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

HTLV I associated myelopathies HTLV I associated T cell leukemia lymphoma HTLV-1 infection Neuritis

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital Universitário Professor Edgard Santos

    RECRUITING

    Salvador, Estado de Bahia, 40110-060, Brazil

More trials for these conditions

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