Status: Recruiting
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
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.
Participants needed: 146
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Carlos BritesUpdated: Jun 2, 2026Locations: 1
Eligibility criteria
Age equal or higher than 18 years [+3]
Active HIV, HCV (RNA+), or HBV (HBsAg+) infection [+8]