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Phase 2RecruitingPriority 2 · High priorityNCT07555431

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

ClinicalTrials.gov

Plain-language summary

This Phase 2 trial is studying Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection and Dolutegravir (DTG) for people with adult T-cell leukemia/lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years or older
  • See full trial listing for complete eligibility

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection (COMBINATION_PRODUCT): 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. | Dolutegravir (DTG) (DRUG): Active comparator will be DTG, 50 mg/day

Drugs / treatments
Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection, Dolutegravir (DTG)
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

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

NCT07555431

Phase: Phase 2 | Status: Recruiting | Priority: High

Plain-language summary

This Phase 2 trial is studying Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection and Dolutegravir (DTG) for people with adult T-cell leukemia/lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join

  • Age 18 Years or older
  • See full trial listing for complete eligibility

What's being tested

Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection (COMBINATION_PRODUCT): 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. | Dolutegravir (DTG) (DRUG): Active comparator will be DTG, 50 mg/day

Drugs / treatments: Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection, Dolutegravir (DTG)

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Randomized, single blind

Enrollment target: 146 patients

Primary endpoint: HTLV-1 Proviral Load; Changes in Pain intensity (DN4 doleur scale); Changes in Spasticity; Changes in muscle strenght; Changes in motor score scales

Ages: 18 Years to —

Start date: 2026-05-07 | Est. completion: 2028-06

Locations

0 US sites · 1 total

Contact

Carlos Brites, MD, PhD | crbrites@gmail.com | +5571992329552

Sponsor: Carlos Brites (OTHER)

Tags

ATLL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07555431

Prepared using TrialCompass (trialcompass.com) on July 4, 2026. For informational purposes only. Always discuss with your healthcare team.