Clinical trial · Interventional
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection (DOT-H): an Open-label, Randomized, Controlled Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HTLV-1 Infection | — | UNRESOLVED | — |
| HTLV I Associated Myelopathies | — | UNRESOLVED | — |
| HTLV I Associated T Cell Leukemia Lymphoma | Adult T-Cell Leukemia/Lymphoma | ALIAS | 0.90 |
| Neuritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection | Combination Product | — | UNRESOLVED |
| Dolutegravir (DTG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dolutegravir
- description
- Dolutegravir 50 mg p.o. daily
- interventionNames
- Drug: Dolutegravir (DTG)
- type
- EXPERIMENTAL
- label
- Combination therapy
- description
- Daily Dolutegravir 50 mg Daily Tenofovir 300 mg
- interventionNames
- Combination Product: Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection
Primary outcomes (5)
- measure
- HTLV-1 Proviral Load
- timeFrame
- From baseline to the end of treatment at 48 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDMarino-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
- BACKGROUNDFernandez 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
- BACKGROUNDFernandez 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
- BACKGROUNDBrites 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