Not Yet RecruitingPhase 2

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

Brazil146 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

HTLV-1 Proviral Load

Timeframe: From baseline to the end of treatment at 48 weeks

Changes in Pain intensity (DN4 doleur scale)

Timeframe: Baeline, 24 and 48 weeks

Changes in Spasticity

Timeframe: BL, 24 and 48 weeks

Changes in muscle strenght

Timeframe: BL, 24 and 48 weeks

Changes in motor score scales

Timeframe: BL, 24, 48 weeks

Trial details

NCT IDNCT07555431

SponsorCarlos Brites

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Carlos Brites, MD, PhD

+5571992329552 crbrites@gmail.com

View on ClinicalTrials.gov More HTLV-1 Infection trials