Dolutegravir with or without Tenofovir for HTLV-1 infection
Official title: Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection (DOT-H): an Open-label, Randomized, Controlled Study.
Run by Fundação Bahiana de Infectologia · NCT07555431 · Data updated 2026-11-12
This phase 2b trial tests whether dolutegravir alone or with tenofovir can lower HTLV-1 proviral load and improve related symptoms in adults with HTLV-1 infection.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 146 (estimated) |
| Sponsor | Fundação Bahiana de Infectologia Academic / other |
| Locations | 1 site (Salvador, Estado de Bahia) |
| Status | Recruiting |
| Started | May 7, 2026 |
| Main results expected | May 2028 |
| Study ends | June 2028 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07555431 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with confirmed HTLV-1 infection and HTLV-1–related clinical manifestations who can provide informed consent.
✕Probably not a fit
Individuals without virological response or with safety concerns may not experience benefit from the regimens tested.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, randomized phase 2b study compares dolutegravir alone to dolutegravir plus tenofovir disoproxil fumarate over 48 weeks in adults with HTLV-1 infection and related clinical manifestations. The primary goal is to see if the treatments reduce HTLV-1 proviral load at 24 and 48 weeks. Secondary outcomes include clinical status, functional abilities, immunological markers, and quality of life. The trial builds on preclinical data suggesting integrase inhibitors may decrease proviral load and considers combination therapy to enhance antiviral effects. Participants will be followed to assess safety and potential virological and clinical benefits.
Why it matters
Potential benefit: If successful, the regimen could reduce viral burden and improve symptoms and daily functioning for people with HTLV-1–related diseases.
How similar studies have gone: Prior pilot data showed partial virological response to dolutegravir, suggesting potential but not yet proven efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Universitário Professor Edgard Santos
Salvador, Estado de Bahia, Brazil Recruiting
Study contacts
- Principal investigator: Carlos Brites, MD, PhD — Hospital Universitário Professor Edgard Santos, Federal University of Bahia
- Study coordinator: Carlos Brites, MD, PhD
- Email: crbrites@gmail.com
- Phone: +5571992329552
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using functional MRI to assess recovery in patients with optic neuritis
This study is testing if a special brain scan can help doctors understand how well patients with optic neuritis are recovering.
-
Combining lenalidomide with standard chemotherapy for adult T-cell leukemia-lymphoma
This study is testing if adding lenalidomide to standard chemotherapy can help adults with T-cell leukemia-lymphoma feel better and live longer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.