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

NCT07555431 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-06-02

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection

In a previous study Dolutegravir was able to reduce HTLV-1 proviral load, but a few patients did not respond to therapy. We intend to use a combination of Dolutegravir + TDF to improve the response rate. There is no previous evidence on the use of such combination for treating HTLV-1 infection.

DRUG

Dolutegravir (DTG)

Active comparator will be DTG, 50 mg/day

Sponsors & Collaborators

  • Carlos Brites

    lead OTHER

Principal Investigators

  • Carlos Brites, MD, PhD · Hospital Universitário Professor Edgard Santos, Federal University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-07
Primary Completion
2028-05-31
Completion
2028-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07555431 on ClinicalTrials.gov