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Studies

Interventional Recruiting Phase 2

NCT07555431 on ClinicalTrials.gov

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

Official title: Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection (DOT-H): an Open-label, Randomized, Controlled Study.

  • Sponsor: Carlos Brites
  • Enrollment: 146 (Estimated)
  • Study start: 2026-05-07 (Actual)
  • Primary completion: 2028-05-01 (Estimated)
  • Study completion: 2028-06-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • HTLV-1 Infection
  • HTLV I Associated Myelopathies
  • HTLV I Associated T Cell Leukemia Lymphoma
  • Neuritis

Intervention / Treatment

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

Primary Outcome Measures

  • HTLV-1 Proviral Load (From baseline to the end of treatment at 48 weeks)
    Measurement of HTLV-1 Proviral Load by RT-PCR. Results will be expressed as copies/ml of whole blood
  • Changes in Pain intensity (DN4 doleur scale) (Baeline, 24 and 48 weeks)
    Change in intensity of pain measured by DN4 doleur scale (0 to 10, with values \>4 indicating neuropathic pain)
  • Changes in Spasticity (BL, 24 and 48 weeks)
    Changes in limbs spasticity, as measured by Ashworth scale. The Ashworth Scale uses a simple ordinal scale ranging from 0 to 4, where the highest values mean increased spasticity
  • Changes in muscle strenght (BL, 24 and 48 weeks)
    Evaluation of muscle strenght by Kendall Muscle Grading system (Kendal scale), which ranges from 0 to 10, with highest values indicating better muscle strenght
  • Changes in motor score scales (BL, 24, 48 weeks)
    Evaluation of changes in motor performance using the lower extremity motor score (LEMS) is a subscale of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that assesses lower extremity muscle strength.The score range is 0-5 for each of 5 key muscles (hip flexors, knee extensors, ankle dorsi-flexors, long toe extensors and ankle plantar flexors) of each leg, with a maximum score of 50 (the lower values indicates worse motor function)

Countries

Brazil

Locations and Investigators

  • Hospital Universitário Professor Edgard Santos, Salvador, Brazil (Recruiting)

Study Officials