Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
Recruiting
Phase 2
Interventional Study
HTLV-1 Infection
HTLV I Associated Myelopathies
HTLV I Associated T Cell Leukemia Lymphoma
Neuritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 146 (estimated)
- Sponsor
- Carlos Brites · Other
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About This Trial
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,…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age equal or higher than 18 years
* Confirmed HTLV-1 infection
* Clinical manifestation atributable to HTLV-1
* Ability to provide written informed consent
Exclusion Criteria:
* Active HIV, HCV (RNA+), or HBV (HBsAg+) infection
* Active tuberculosis
* Recent corticosteroid u…
Contacts