About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)
DrugEnrolled 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Virological efficacy
Proportion of participants with HIV-1 RNA pVL \>= 50 copies/mL at week 48 as per-protocol (PP) analysis.
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.
Changes in CD4+ count
Absolute values and change from baseline in CD4+ lymphocyte count at weeks 24 and 48.
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).
Sponsors and contacts
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UBATEC
Lead sponsor
Hospital Fernandez
Sponsor institution
ViiV Healthcare
Collaborator
Hospital Fernandez
Collaborator