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

Recruiting now · Phase 2

Conditions studied: HTLV-1 Infection, HTLV I Associated Myelopathies, HTLV I Associated T Cell Leukemia Lymphoma, Neuritis

In brief

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.

Key facts

Study ID

NCT07555431

Run by

Carlos Brites

People needed

146

Starts

2026-05-07

Expected to finish

2028-06-01

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Hospital Universitário Professor Edgard Santos — Salvador, Estado de Bahia, Brazil (enrolling)

Full record on ClinicalTrials.gov

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