HIVPhase 4TRANS-SWITCHNCT06967753
Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)
A Phase 4 study testing Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG) in people with HIV and HIV-1, run by UBATEC at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteArgentina
- Study dates
- 31 Jul 2025to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
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- 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.
Who cannot join
- 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.
- Evidence of an active centers for disease control and prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/millimeter are not exclusionary. Those individuals who are stable and receiving appropriate treatment for an HIV/AIDS-associated disease can be considered for the study.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
Hospital General de Agudos Dr. Juan A. Fernández, Infectious Diseases Division
Buenos Aires, Buenos Aires F.D., 1425
María J Rolón, MD, +5411 4808-2600 ext. 1040, mjrolon@gmail.com
José AE Barletta, MD, +5411 4808-2600 ext. 1040, jbarletta@buenosaires.gob.ar
About this study
Official title: Switch to Dolutegravir Plus Lamivudine Dual-therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)
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.
Read the detailed description
This is a phase IV, 48-week, prospective, open-label, and single arm study. Study population will include 50 TGW living with HIV on suppressive ART. Eligible participants will be switched to a 2DR base of DTG + 3TC once daily and follow-up period will be 48 weeks.
The study timeline will consist of:
- a selection period of up to 30 days,
- a 48-week treatment period,
- and a 4-week post-treatment follow-up period.
The aim of the study will be to explore the effectiveness, safety, and acceptability of DTG + 3TC dual therapy among TGW living with HIV.
- Being tested
- Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)
- Keywords
- dual therapy, dolutegravir, antiretroviral treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (12)
Virological efficacy
Proportion of participants with HIV-1 RNA pVL >= 50 copies/mL at week 48 as per-protocol (PP) analysis.
Measured: 48 weeks
Virological efficacy
Proportion of participants with HIV-1 RNA pVL >= 50 copies/mL at 24 weeks of treatment as per the ITT-E snapshot FDA algorithm.
Measured: 24 weeks
Changes in CD4+ count
Absolute values and change from baseline in CD4+ lymphocyte count at weeks 24 and 48.
Measured: 24 and 48 weeks
Safety - Adverse Events (including Serious Adverse Events and Adverse Events Leading to Discontinuation)
Number of participants with any AEs, SAEs, AEs by their severity grades, and AEs leading to discontinuation through 48 weeks. AE will be evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death).
Measured: 48 weeks
Changes in lipid profile measurements
Change from baseline in serum or plasma total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides at weeks 24 and 48. Fasting blood samples will be collected to assess total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-dose assessment. Change from baseline is defined as post-dose visit value minus baseline value.
Measured: 24 and 48 weeks
Changes in Kidney Function measurements
Change from baseline in plasma creatinine at weeks 24 and 48. Blood samples will be collected to perform assess serum or plasma creatinine at week 24 and 48. Baseline value is defined as the latest pre-dose assessment. Change from baseline was calculated as post-dose visit value minus baseline value.
Measured: 24 and 48 weeks
Changes in Body Weight
Change from baseline in absolute body weight and Body Mass Index (BMI) at weeks 24 and 48. Baseline value is defined as the latest pre-dose assessment.
Measured: 24 and 48 weeks
Changes in Bone Mineral Density
Percent change from baseline in Bone Mineral Density (BMD) of the hip and lumber spine to week 48. BMD will be evaluated by dual-energy x-ray absorptiometry (DEXA) scans at study baseline and week 48.
Measured: 48 weeks
Emerging resistance to study drugs
Number of participants with confirmed virological failure as per the protocol with observed genotypic resistance to DTG and/or 3TC.
Measured: 48 weeks
Quality of LIfe
Change from Baseline in health-related quality of life using European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) and Patient Health Questionnaire-9 (PHQ-9) at baseline and weeks 4, 24 and 48.
Measured: Weeks 4, 24 and 48
Treatment acceptance
Change from Baseline in HIV treatment acceptance using Treatment Satisfaction Questionnaire change version (HIVTSQc) and Chronic Treatment Acceptance questionnaire (ACCEPT) at baseline and weeks 4, 24 and 48.
Measured: Weeks 4, 24 and 48
Treatment Adherence
Adherence using the ACTG adherence questionnaire at baseline and weeks 4, 12, 24, 36 and 48
Measured: Weeks 4, 12, 24, 36 and 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start31 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UBATEC
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, Hospital Fernandez
- Responsible party
- Principal investigator, Martin Jaume, Hospital Fernandez
- Investigators
- Martín Jaume, MD, Principal investigator, Hospital Fernández, Infectious Diseases Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967753
- Sponsor's protocol ID
- PRIISA 14399
- Acronym
- TRANS-SWITCH
- Status last verified
- Sep 2025
- First submitted
- 20 Apr 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch to Dolutegravir Plus Lamivudine Dual-therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)
- ClinicalTrials.gov ID
- NCT06967753
- Acronym / sponsor ID
- TRANS-SWITCH / PRIISA 14399
- Keywords
- dual therapy, dolutegravir, antiretroviral treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UBATECUniversity, hospital or other
- Collaborators
- ViiV Healthcare, Hospital Fernandez
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase IV, 48-week, prospective, open-label, and single arm study. Study population will include 50 TGW living with HIV on suppressive ART. Eligible participants will be switched to a 2DR base of DTG + 3TC once daily and follow-up period will be 48 weeks.
The study timeline will consist of:
- a selection period of up to 30 days,
- a 48-week treatment period,
- and a 4-week post-treatment follow-up period.
The aim of the study will be to explore the effectiveness, safety, and acceptability of DTG + 3TC dual therapy among TGW living with HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This will be a single-arm study | Experimental | Drug: Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 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.
Key exclusion criteria (14 listed)
- 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.
- Evidence of an active centers for disease control and prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/millimeter are not exclusionary. Those individuals who are stable and receiving appropriate treatment for an HIV/AIDS-associated disease can be considered for the study.
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma, or anal or penile intraepithelial neoplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | This will be a single-arm study |
Primary outcome
Virological efficacy
Time frame: 48 weeks
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.
12 secondary outcomes
Virological efficacy
Time frame: 48 weeks
Virological efficacy
Time frame: 24 weeks
Changes in CD4+ count
Time frame: 24 and 48 weeks
Safety - Adverse Events (including Serious Adverse Events and Adverse Events Leading to Discontinuation)
Time frame: 48 weeks
Changes in lipid profile measurements
Time frame: 24 and 48 weeks
Changes in Kidney Function measurements
Time frame: 24 and 48 weeks
Changes in Body Weight
Time frame: 24 and 48 weeks
Changes in Bone Mineral Density
Time frame: 48 weeks
Emerging resistance to study drugs
Time frame: 48 weeks
Quality of LIfe
Time frame: Weeks 4, 24 and 48
Treatment acceptance
Time frame: Weeks 4, 24 and 48
Treatment Adherence
Time frame: Weeks 4, 12, 24, 36 and 48.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martín Jaume, MD principal investigator
Hospital Fernández, Infectious Diseases Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG) in people with HIV and HIV-1, run by UBATEC at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martín Jaume, MD (+54 11 4808-2600 ext. 1040, martinjaume27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virological efficacy (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.