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.

Trial Details

NCT ID
NCT07555431
Phase
PHASE2
Sponsor
Carlos Brites
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection
  • Dolutegravir (DTG)
Locations (sample)
  • Salvador, Estado de Bahia, Brazil|-12.97563,-38.49096

Key Eligibility Criteria

  • Age equal or higher than 18 years
  • Confirmed HTLV-1 infection
  • Clinical manifestation atributable to HTLV-1
  • Ability to provide written informed consent

For full eligibility, visit ClinicalTrials.gov.

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