RecruitingPhase 4NCT06967753

Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)

Switch to Dolutegravir Plus Lamivudine Dual-therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)

Sponsor

UBATEC

Enrollment

50 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

HIV HIV-1

Summary

This single-arm, open label study is aimed to assess efficacy and safety of dolutegravir plus lamivudine as a switch strategy among TGW with HIV receiving suppresive antiretroviral therapy.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether transgender women living with HIV can safely switch to a simpler two-drug antiretroviral regimen (dolutegravir plus lamivudine) from their current multi-drug treatment, while keeping the virus fully suppressed. **You may be eligible if...** - You are 18 or older and identify as a transgender woman - You have a confirmed HIV-1 diagnosis - You are currently on antiretroviral therapy and your viral load is undetectable - You have been on your current HIV treatment for at least 6 months - You are willing to use contraception if applicable **You may NOT be eligible if...** - Your HIV virus is not currently suppressed (detectable viral load) - You have resistance to the study drugs - You have significant kidney or liver problems - You are pregnant or breastfeeding - You have a history of treatment failure on similar drug classes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)

Enrolled participants will be switched to a dual therapy regimen consisting of 50-mg DTG plus 300-mg 3TC tablet (as a single pill fixed dose combination) orally administered once daily with or without food. No dose reductions, modifications in dosage, or changes in the frequency of dosing will be allowed in this study.