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

NCT06967753 | Recruiting Phase 4

• 1 other identifier: PRIISA 14399
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

HIV; HIV-1

Keywords

dual therapy; dolutegravir; antiretroviral treatment

Outcome Measures

Primary Outcomes (1)

• Virological efficacy

  Proportion of participants with HIV-1 RNA pVL \>= 50 copies/mL at 48 weeks of treatment as per the intent-to-treat exposed (ITT-E) snapshot FDA algorithm.

  48 weeks

Secondary Outcomes (12)

• Virological efficacy

  48 weeks

• Virological efficacy

  24 weeks

• Changes in CD4+ count

  24 and 48 weeks

• Safety - Adverse Events (including Serious Adverse Events and Adverse Events Leading to Discontinuation)

  48 weeks

• Changes in lipid profile measurements

  24 and 48 weeks

Study Arms (1)

This will be a single-arm study

EXPERIMENTAL

Enrolled participants will be switched to a dual therapy strategy 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.

Drug: Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)

Interventions

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

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.

This will be a single-arm study

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older at the time of signing the informed consent.
• Self-identified as TGW.
• Documented HIV-1 infection as per local standard: HIV-1 positive serology by at least two different serological tests (rapid test, ELISA, Western Blot) or a plasma HIV RNA viral ≥1,000 copies/mL.
• ART-experienced participant on uninterrupted, stable, and suppressive triple ART for at least 3 months prior to screening, including: a) Acceptable stable ART regimens prior to Screening include 2 NRTIs plus i) INSTI ii) NNRTI or iii) Boosted PI. b) Any prior switch, defined as a change of a single drug or multiple drugs, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification and must not have been done for suspected or established treatment failure. The following switches, if they are the only switches, would not be considered a change in regimen. a) A switch from a PI boosted with ritonavir (RTV) to the same PI boosted with cobicistat is allowed (and vice versa). b) A switch from 3TC to emtricitabine (FTC) (and vice versa). c) A switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) (and vice versa).
• Documented evidence of at least two HIV-1 RNA pVL \<50 copies/mL in the last 12 months. HIV-1 RNA pVL corresponding to the screening visit may be accepted as second measurement.
• Evidence of HIV-1 RNA pVL \<50 copies/mL at screening visit.
• Do not have history of previous virological failure and/or evidence of resistance to DTG or 3TC as per protocol definition.
• Participants must be able to understand and comply with protocol.
• Written informed consent provided.

You may not qualify if:

• History or presence of hypersensitivity to any of the study drugs or their components.
• Evidence of known acute or chronic viral hepatitis B (positive Hepatitis B surface antigen \[HBsAg\]) or hepatitis C (detectable plasma HCV RNA viral load). Participants with chronic Hepatitis B (positive HBsAg) or Hepatitis C (positive plasma HCV RNA viral load) will be excluded. Individuals with evidence of previous Hepatitis B (positive for Hepatitis B core antibody \[HBcAc\] but negative HBsAg may be included on the trial. Individuals with positive anti-HCV antibodies but with non-detectable plasma HCV RNA (previously treated or spontaneously cleared HCV) may be included in the study.
• Evidence of untreated syphilis infection (positive VDRL at screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.
• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma, or anal or penile intraepithelial neoplasia.
• Participants with severe hepatic impairment (Class C) as determined by Child Pugh classification.
• Any evidence of preexisting viral resistance based on the presence of any NRTI or INSTI major resistance associated mutation as per IAS-USA 2022 resistance panel in any historical resistance test result. 3TC resistance is considered in the presence of the M184V/I and/or K65R and/or Q151M mutations. DTG resistance is considered in the presence of the G118R, E138A/K/TG140A/C/R/S, Q148H/K/R, S153F/Y, N155H, or R263K mutations.
• Participants who, as per the investigator's judgment, poses a significant suicidality risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.
• Receiving other medications with relevant interactions with DTG and/or 3TC.
• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
• Treatment with any of the following agents within 28 days of screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
• Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of the study drug.
• Laboratory tests performed at the screening visit show any of the following results: a. Any verified Grade 4 laboratory abnormality. b. Hemoglobin \<9.0 g/dL c. Absolute neutrophil count \<750 cel/µL d. Platelet count \<80,000 cel/mm3 e. Creatinine clearance \<30 mL/min according to the Cockroft-Gault formula. f. Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN) or ALT ≥3 times ULN and bilirubin ≥1.5 times ULN (with \>35% direct bilirubin).
• Any condition (including but not limited to the abuse of alcohol or drugs) which in the opinion of the investigator could compromise the participant's safety or adherence to the protocol.

Sponsors & Collaborators

• UBATEC: lead
• ViiV Healthcare: collaborator
• Hospital Fernandez: collaborator

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Interventions

dolutegravir; Lamivudine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Martín Jaume, MD

  Hospital Fernández, Infectious Diseases Division

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martín Jaume, MD

CONTACT

+54 11 4808-2600; martinjaume27@gmail.com

José AE Barletta, MD

CONTACT

+54 11 4808-2600; jbarletta@buenosaires.gob.ar

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: May 13, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

AR (1)