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.
Carlos Brites
146 participants
May 7, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Age equal or higher than 18 years
- Confirmed HTLV-1 infection
- Clinical manifestation atributable to HTLV-1
- Ability to provide written informed consent
Exclusion Criteria9
- 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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Interventions
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.
Active comparator will be DTG, 50 mg/day
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07555431