Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection (DOT-H): an Open-label, Randomized, Controlled Study.
Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age equal or higher than 18 years
• Confirmed HTLV-1 infection
• Clinical manifestation atributable to HTLV-1
• Ability to provide written informed consent
Locations
Other Locations
Brazil
Hospital Universitário Professor Edgard Santos
RECRUITING
Salvador
Contact Information
Primary
Carlos Brites, MD, PhD
crbrites@gmail.com
+5571992329552
Backup
Estela Luz
eluz5@yahoo.com.br
+5571999867515
Time Frame
Start Date: 2026-05-07
Estimated Completion Date: 2028-06
Participants
Target number of participants: 146
Treatments
Active_comparator: Dolutegravir
Dolutegravir 50 mg p.o. daily
Experimental: Combination therapy
Daily Dolutegravir 50 mg Daily Tenofovir 300 mg
Related Therapeutic Areas
Sponsors
Leads: Carlos Brites