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Compares treatment options for HTLV-1 Infection
Official title Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
ClinicalTrials.gov ID: NCT07555431
What this study is testing
What is Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection?
Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection is an investigational medicine, being studied as a potential treatment for htlv-1 infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age equal or higher than 18 years
- Confirmed HTLV-1 infection
- Clinical manifestation atributable to HTLV-1
- Ability to provide written informed consent
You likely can't join if
- Active HIV, HCV (RNA+), or HBV (HBsAg+) infection
- Active tuberculosis
- Recent corticosteroid use
- Renal impairment (CrCl \<50 mL/min)
- Autoimmune diseases
- Wheelchair-bound individuals
See the full eligibility criteria
- Age equal or higher than 18 years
- Confirmed HTLV-1 infection
- Clinical manifestation atributable to HTLV-1
- Ability to provide written informed consent
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Salvador, Estado de Bahia, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salvador, Estado de Bahia, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.