Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Dolutegravir + Lamivudine FDC
Intervention description: Dolutegravir + Lamivudine FDC is available as white oval film-coated tablets which are packed in high density polyethylene (HDPE) bottles with induction seals and child-resistant closures. Each 60 milliliter (mL) bottle contains 30 tablets
Intervention MeSH terms: Lamivudine; Dolutegravir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will receive 50 mg DTG + 300 mg 3TC FDC, participants will administer one tablet once daily (OD) orally with or without food.
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GSK3515864, dolutegravir, Dovato, lamivudine, 3TC, HIV-1, Test and Treat

Summary:

      Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for
      individuals infected with HIV. Suppressing viral replication with ART also reduces the
      potential for transmission of HIV. Hence, ART is recommended for all persons with HIV viremia
      regardless of cluster of differentiation 4 (CD4) count. This is an open-label single arm
      which will evaluate the feasibility, efficacy and safety using a fixed dose combination (FDC)
      of Dolutegravir (DTG) plus Lamivudine (3TC) as a first line regimen of a rapid Test and Treat
      model of care over 48 weeks. Participants with new and confirmed diagnosed HIV-1 who are
      willing to start study treatment immediately following diagnosis will receive 50 milligram
      (mg) DTG + 300 (mg) 3TC FDC as first line therapy without waiting for screening laboratory
      results, at the Screening/Day 1 Visit. The total duration for the study will be 52 weeks and
      4 weeks of follow up period if required. This study will be conducted in United States (US)
      with approximately 120 participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible participants must be able to understand and comply with protocol
             requirements, instructions, and restrictions.

          -  Eligible participants must be likely to complete the study as planned.

          -  Eligible participants must be considered appropriate candidates for participation in
             an investigative clinical trial with oral medication (e.g. no active problematic
             substance abuse, acute major organ disease, or potential long-term work assignments
             out of the country).

          -  Participant must be more than or equal to 18 at the time of signing the informed
             consent.

          -  Participants must have a new and confirmed diagnosis of HIV-1 infection and are
             willing to initiate ART immediately (or, for those participants referred from another
             site, within 14 days of initial diagnosis at the external clinic/testing center).

          -  Participant must have an initial positive rapid HIV test and participant has a second
             positive confirmatory rapid HIV test, using a test kit from a different manufacturer
             than the first test or participant has been identified as HIV-1 infected using an
             FDA-approved 4th generation assay antigen/antibody combination immunoassay or 3rd
             generation immunoassay that detects and differentiates HIV-1 and HIV-2 antibodies;
             participant has a confirmatory HIV western blot or an HIV-1 RNA or participant has a
             positive FDA-approved 4th generation assay and a positive 3rd generation immunoassay
             that detects and differentiates HIV-1 and HIV-2 antibodies.

          -  Antiretroviral-naïve. Participants who received HIV post-exposure prophylaxis (PEP) or
             pre-exposure prophylaxis (PrEP) in the past are allowed as long as the last PEP/PrEP
             dose was more than 6 months from HIV diagnosis or there is documented HIV
             seronegativity at least 2 months after the last prophylactic dose and prior to the
             date of HIV diagnosis.

          -  Male and/or female participants.

          -  Participants who are female at birth are eligible to participate if at least one of
             the following conditions applies: Not pregnant [as confirmed by a negative urine human
             chorionic gonadotropin (hCG) test at Screening/Day 1.

          -  Pregnant and post the first trimester (the physician and patient should decide whether
             enrolling in this study is in the participants best interest during the consent
             process)

          -  Not a participant of childbearing potential (POCBP) or a POCBP agrees to follow the
             contraceptive guidance, is currently taking hormonal contraceptives and continues for
             at least 2 weeks after the last dose of study medication. Participants who are female
             at birth and who are in the following categories are not considered POCBP,
             premenarchal, premenopausal female with one of the following: documented hysterectomy,
             documented bilateral salpingectomy, documented bilateral oophorectomy or
             postmenopausal, a postmenopausal state is defined as no menses for 12 months without
             an alternative medical cause; a high follicle stimulating hormone (FSH) level in the
             postmenopausal range may be used to confirm a postmenopausal state in participants who
             are female at birth and not using hormonal contraception or hormonal replacement
             therapy (HRT); participants who are female at birth on HRT and whose menopausal status
             is in doubt will be required to use one of the non-hormonal highly effective
             contraception methods if they wish to continue their HRT during the study.

          -  Participants who are capable of giving signed informed consent which includes
             compliance with the requirements and restrictions listed in the informed consent form
             (ICF) and in this protocol.

        Exclusion Criteria:

          -  Participants who are breastfeeding, plan to become pregnant or breastfeed during the
             study.

          -  Participants who are in their first trimester of pregnancy.

          -  HIV-1 drug resistance genotype test results are known prior to Screening/Day 1.

          -  Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3
             disease except for esophageal candidiasis and cutaneous Kaposi's sarcoma not requiring
             systemic therapy.

          -  Participants with known or suspected Hepatitis B infection.

          -  Participants with known or suspected severe hepatic impairment or unstable liver
             disease (as defined by the presence of ascites, encephalopathy, coagulopathy,
             hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis,
             known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic
             gallstones).

          -  Participants with known moderate to severe renal impairment (creatinine clearance less
             than 30ml/minute per 1.73 square meter);

          -  Participant with ongoing malignancy other than basal cell carcinoma, or resected,
             non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile
             intraepithelial neoplasia; other localized malignancies require agreement between the
             investigator and the Study Medical Monitor for inclusion of the participant.

          -  Participants who in the investigator's judgment, poses a significant suicidality risk.

          -  Participants with any pre-existing physical or mental condition which, in the opinion
             of the Investigator, may interfere with the participant's ability to comply with the
             dosing schedule and/or protocol evaluations or which may compromise the safety of the
             participant.

          -  Participants with substance abuse disorders or social restraints that the Investigator
             considers to be possible deterrents to successful initiation of ART.

          -  Participants with history or presence of allergy or intolerance to the study drugs or
             their components.

          -  Participants with treatment with any of the following agents within 28 days of the
             first dose of study treatment, radiation therapy, cytotoxic chemotherapeutic agents,
             any systemic immune suppressant.

          -  Participants receiving any prohibited medication and who are unwilling or unable to
             switch to an alternate medication.

          -  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 study treatment.