Actively Recruiting

Phase 4
Age: 18Years +
MALE
NCT06967753

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

Led by UBATEC · Updated on 2025-09-12

50

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

U

UBATEC

Lead Sponsor

V

ViiV Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at the time of signing informed consent
  • Self-identified as transgender women
  • Documented HIV-1 infection confirmed by at least two different serological tests or plasma HIV RNA viral load ≥1,000 copies/mL
  • On uninterrupted, stable, and suppressive triple antiretroviral therapy for at least 3 months prior to screening with acceptable regimens
  • Documented evidence of at least two HIV-1 RNA plasma viral loads below 50 copies/mL in the last 12 months
  • HIV-1 RNA plasma viral load below 50 copies/mL at screening visit
  • No history of virological failure or resistance to dolutegravir or lamivudine as defined in the protocol
  • Ability to understand and comply with study protocol
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • History or presence of hypersensitivity to study drugs or components
  • Known acute or chronic hepatitis B or hepatitis C infection (positive HBsAg or detectable HCV RNA)
  • Untreated syphilis infection (positive VDRL without documented treatment)
  • Evidence of active CDC Stage 3 disease except cutaneous Kaposi's sarcoma not needing systemic therapy
  • Ongoing malignancy other than specified skin cancers or anal/penile intraepithelial neoplasia
  • Severe hepatic impairment (Child Pugh Class C)
  • Presence of major resistance mutations to NRTI or INSTI drugs based on historical tests
  • Significant risk of suicidality as judged by investigator
  • Use of medications with interactions with dolutegravir and/or lamivudine
  • Treatment with HIV-1 immunotherapeutic vaccine within 90 days prior to screening
  • Treatment with radiation therapy, cytotoxic chemotherapy, or systemic immune suppressants within 28 days
  • Exposure to experimental drugs or vaccines within specified time frames before first study dose
  • Laboratory abnormalities including Grade 4 values, low hemoglobin, neutrophils, platelets, low creatinine clearance, or elevated liver enzymes
  • Any condition that may compromise safety or adherence according to investigator judgement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital General de Agudos Dr. Juan A. Fernández, Infectious Diseases Division

Buenos Aires, Buenos Aires F.D., Argentina, 1425

Actively Recruiting

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Research Team

M

Martín Jaume, MD

CONTACT

J

José AE Barletta, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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