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

RecruitingPhase 2Ages 18 Years - anyAllCarlos Brites
NCT07555431 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age equal or higher than 18 years * Confirmed HTLV-1 infection * Clinical manifestation atributable to HTLV-1 * Ability to provide written informed consent Exclusion Criteria: * 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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What it tests

  • Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection
  • Dolutegravir (DTG)
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Where

1 site
Hospital Universitário Professor Edgard Santos
Salvador, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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