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.
Age equal or higher than 18 years
Confirmed HTLV-1 infection
Clinical manifestation atributable to HTLV-1
Ability to provide written informed consent
Active HIV, HCV (RNA+), or HBV (HBsAg+) infection
Active tuberculosis
Recent corticosteroid use
Renal impairment (CrCl <50 mL/min)
Carlos Brites
Lead sponsor
Fundação Bahiana de Infectologia
Sponsor institution