Actively Recruiting
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
8 weeks
Total Duration
On this page
Sponsors
U
UBATEC
Lead Sponsor
V
ViiV Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the effectiveness and safety of a dual therapy combining dolutegravir and lamivudine as a switch strategy for transgender women living with HIV who are already on suppressive antiretroviral therapy. The study is a phase IV, open-label, single-arm trial involving 50 participants identifying as transgender women. It focuses on exploring how well this dual therapy works and how acceptable it is among this population. Participants will switch from their current antiretroviral regimen to a fixed-dose combination tablet containing 50 mg dolutegravir and 300 mg lamivudine taken orally once daily, with or without food. The treatment period lasts 48 weeks following a selection period of up to 30 days, and concludes with a 4-week post-treatment follow-up. No dose adjustments or changes in dosing frequency are permitted during the study. During the study, participants will be monitored through clinical evaluations, laboratory tests, and assessments of HIV viral load to measure virological efficacy at 48 weeks. Additional outcomes include safety evaluations, changes in immune cell counts, lipid profiles, kidney function, body weight, bone mineral density, resistance development, quality of life, treatment acceptance, and adherence. These measures will be collected at various time points throughout the 48-week treatment and follow-up period to provide a comprehensive understanding of the therapy's impact.
CONDITIONS
Brief Title
Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of signing informed consent
- Self-identify as transgender women (TGW)
- Documented HIV-1 infection confirmed by at least two different serological tests or plasma HIV RNA viral load ≥1,000 copies/mL
- On stable, uninterrupted, suppressive triple antiretroviral therapy (ART) for at least 3 months before screening
- Have documented HIV-1 RNA plasma viral load below 50 copies/mL in the last 12 months and at screening
- No history of previous virological failure or resistance to dolutegravir or lamivudine
- Able to understand and comply with the study protocol
- Provide written informed consent
You will not qualify if you...
- History or presence of hypersensitivity to study drugs or their components
- Known acute or chronic hepatitis B or hepatitis C infection with detectable viral load
- Untreated syphilis infection at screening
- Active CDC Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy
- Ongoing malignancies except certain skin cancers or intraepithelial neoplasia
- Severe hepatic impairment (Child Pugh Class C)
- Evidence of major resistance mutations to NRTI or INSTI drugs
- Significant risk of suicidality as judged by investigator
- Use of medications with relevant interactions with dolutegravir or lamivudine
- Recent treatment with immunotherapeutic vaccines, radiation, cytotoxic chemotherapy, or systemic immune suppressants
- Exposure to experimental drugs or vaccines within specified timeframes prior to study
- Laboratory abnormalities including severe anemia, low neutrophils or platelets, low kidney function, or elevated liver enzymes
- Any condition compromising safety or adherence, including substance abuse
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 30 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 48 weeks
Participants switch to a dual therapy regimen of Dolutegravir plus Lamivudine taken once daily to explore effectiveness, safety, and acceptability.
Visits at Weeks 4, 12, 24, 36, and 48 for treatment adherence and safety assessments
Duration - 4 weeks
Participants are monitored for safety and outcomes after completing treatment.
1 follow-up visit (in-person) after treatment ends
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
Research Team
M
Martín Jaume, MD
J
José AE Barletta, MD
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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