Clinical Trial

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

Study acronym: DOT-H
Recruiting Phase 2
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-03
Trial Details
NCT Number NCT07555431
Lead Sponsor Carlos Brites
Conditions HTLV-1 Infection, HTLV I Associated Myelopathies, HTLV I Associated T Cell Leukemia Lymphoma, Neuritis
Enrollment 146 participants
Start Date 2026-05-07
Primary Completion 2028-05 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-02