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New treatment option for HIV
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
What this study is testing
What is Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)?
Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- ART-experienced participant on uninterrupted, stable, and suppressive triple ART for at least 3 months prior to screening, including: a) Acceptable...
- 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...
You likely can't join 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...
- Evidence of untreated syphilis infection (positive VDRL at screening without clear documentation of treatment). Participants who are at least 7 days...
- Evidence of an active centers for disease control and prevention (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic...
- Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma, or anal or...
- Participants with severe hepatic impairment (Class C) as determined by Child Pugh classification.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- Laboratory tests performed at the screening visit show any of the following results: a. Any verified Grade 4 laboratory abnormality. b. Hemoglobin \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Buenos Aires F.D., Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Buenos Aires F.D., Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.