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Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
Sponsor: Carlos Brites
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.
Official title: Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection (DOT-H): an Open-label, Randomized, Controlled Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2026-04
Completion Date
2028-06
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
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.
Dolutegravir (DTG)
Active comparator will be DTG, 50 mg/day
Locations (1)
Hospital Universitário Professor Edgard Santos
Salvador, Estado de Bahia, Brazil