Menu
Recruiting NCT07555431

Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection

Phase II Interventional HTLV-1 Infection HTLV I Associated Myelopathies HTLV I Associated T Cell Leukemia Lymphoma Neuritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection, Dolutegravir (DTG).
Who it may be relevant to
Registry conditions: HTLV-1 Infection, HTLV I Associated Myelopathies, HTLV I Associated T Cell Leukemia Lymphoma, Neuritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection (DOT-H): an Open-label, Randomized, Controlled Study.

Overview

This phase 2b, open-label, randomized controlled trial evaluates the efficacy and safety of dolutegravir (DTG) alone versus dolutegravir combined with tenofovir disoproxil fumarate (TDF) in individuals with HTLV-1 infection and associated clinical manifestations. The primary objective is to compare changes in HTLV-1 proviral load at 24 and 48 weeks. Secondary outcomes include clinical, functional, immunological, and quality-of-life measures.

Detailed description

Human T-lymphotropic virus type 1 (HTLV-1) infection is a neglected condition associated with severe neurological and hematological diseases, including HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP). Currently, no effective antiviral therapy exists.

Preclinical and clinical data suggest that integrase inhibitors such as dolutegravir may reduce HTLV-1 proviral load. Additionally, combination therapy with tenofovir may enhance antiviral activity. This study builds on prior pilot data demonstrating partial virological response to DTG.

Participants will be randomized (1:1) to receive DTG alone or DTG plus TDF for 48 weeks. Outcomes will include virological, immunological, clinical, and patient-reported measures. The study aims to provide evidence for therapeutic strategies targeting HTLV-1.

Interventions

  • Combination product Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection
    In a previous study Dolutegravir was able to reduce HTLV-1 proviral load, but a few patients did not respond to therapy. We intend to use a combination of Dolutegravir + TDF to improve the response rate. There is no previous evidence on the use of such combination for treating HTLV-1 infection.
  • Drug Dolutegravir (DTG)
    Active comparator will be DTG, 50 mg/day

Primary outcome measures

  • HTLV-1 Proviral Load [Time frame: From baseline to the end of treatment at 48 weeks]
  • Changes in Pain intensity (DN4 doleur scale) [Time frame: Baeline, 24 and 48 weeks]
  • Changes in Spasticity [Time frame: BL, 24 and 48 weeks]
  • Changes in muscle strenght [Time frame: BL, 24 and 48 weeks]
  • Changes in motor score scales [Time frame: BL, 24, 48 weeks]
Secondary outcome measures (3)
  • Nocturia frequency [Time frame: Baseline, 24 and 48 weeks]
  • Cytokines levels [Time frame: BL, 24 and 48 weeks]
  • RAND 36-Item Health Survey [Time frame: Baseline and at 48 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Hospital Universitário Professor Edgard Santos — Salvador

Publications

  • Marino-Merlo F, Balestrieri E, Matteucci C, Mastino A, Grelli S, Macchi B. Antiretroviral Therapy in HTLV-1 Infection: An Updated Overview. Pathogens. 2020 May 1;9(5):342. doi: 10.3390/pathogens9050342. PMID 32369988
  • Fernandez T, Marconi C, Montano-Castellon I, Deminco F, Brites C. A Systematical Review on ART Use in HTLV Infection: Clinical, Virological, and Immunological Outcomes. Pathogens. 2024 Aug 27;13(9):721. doi: 10.3390/pathogens13090721. PMID 39338913
  • Fernandez T, Arriaga MB, Mayoral R, Netto EM, Brites C. Dolutegravir use is related to lower HTLV-1 proviral load in people co-infected by HIV-1. Commun Med (Lond). 2025 Dec 18;6(1):54. doi: 10.1038/s43856-025-01312-9. PMID 41413309
  • Brites C, Montano-Castellon I, Arriaga MB, Marconi C, Mayoral R, Luz E, Figueredo CA, Fiuza BSD, Netto EM. Dolutegravir Reduces Human T-Cell Lymphotropic Virus Type 1 Proviral Load and Improves Neurological Outcomes in a Phase 2 Controlled Trial. Clin Infect Dis. 2026 May 20;82(5):e910-e920. doi: 10.1093/cid/ciag163. PMID 41834485

Identifiers

NCT: NCT07555431 · FBAI-001/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗