Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
About this study
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.
- Condition
- HTLV-1 Infection, HTLV I Associated Myelopathies, HTLV I Associated T Cell Leukemia Lymphoma, Neuritis
- Tested
- Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection, Dolutegravir (DTG)
- Sponsor
- Carlos Brites
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: HTLV-1 Infection, HTLV I Associated Myelopathies, HTLV I Associated T Cell Leukemia Lymphoma, Neuritis
- Age equal or higher than 18 years
- Confirmed HTLV-1 infection
- Clinical manifestation atributable to HTLV-1
- Ability to provide written informed consent
Exclusion 9
- 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
1 site, 1 recruiting
Hospital Universitário Professor Edgard Santos
Salvador, Estado de Bahia, Brazil
Contact
-
Carlos Brites, MD, PhD
+5571992329552 crbrites@gmail.com
-
Estela Luz
+5571999867515 eluz5@yahoo.com.br
Potential match only. Final eligibility is determined by the study team.