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

RECRUITINGPhase 2Sponsored by Carlos Brites
Actively Recruiting
PhasePhase 2
SponsorCarlos Brites
Started2026-05-07
Est. completion2028-05
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07555431

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

CancerHTLV I Associated MyelopathiesHTLV I Associated T Cell Leukemia LymphomaHTLV-1 InfectionNeuritis

Interventions1

Dolutegravir (DTG)

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