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

NCT06967753 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dolutegravir 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.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Hospital Fernandez

    collaborator OTHER

  • UBATEC

    lead OTHER

Principal Investigators

  • Martín Jaume, MD · Hospital Fernández, Infectious Diseases Division

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06967753 on ClinicalTrials.gov