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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults

Clinicaltrials.gov identifier NCT03945981

Recruitment Status Active, not recruiting

First Posted May 10, 2019

Last update posted October 2, 2020

Study Description

Brief 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.

  • Condition or Disease:HIV Infections
  • Intervention/Treatment: Drug: Dolutegravir + Lamivudine FDC
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 131 participants
  • 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) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 3b Multi-center, Open Label, Single Arm, 52-week Study, Evaluating the Feasibility, Efficacy and Safety of Rapid Test and Treat Intervention in Newly Diagnosed HIV-1 Infected Adults Using a Fixed Dose Combination of Dolutegravir Plus Lamivudine (DOVATO) as a First Line Regimen
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: April 2020
  • Actual Study Completion Date: October 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Participants receiving Dolutegravir + Lamivudine FDC
Participants will receive DTG 50mg and 3TC 300 mg FDC tablet orally once daily (OD) with or without food
Drug: Dolutegravir + Lamivudine FDC
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
Outcome Measures
  • Primary Outcome Measures: 1. Number of Participants with plasma HIV-1 Ribonucleic acid (RNA) less than 50 copy/milliliter (c/mL) regardless of ART regimen (observed analysis) [ Time Frame: At Week 24 ]
    Blood samples will be collected to assess the number of participants with plasma HIV-1 RNA less than 50 c/mL analyzed with observed analysis.
  • Secondary Outcome Measures: 1. Number of participants who have HIV-RNA less than 50 c/mL regardless of ART regimen (observed analysis) [ Time Frame: At Week 48 ]
    Blood samples will be collected to assess the number of participants with plasma HIV-1 RNA less than 50 c/mL analyzed with observed analysis.
  • 2. Number of participants with plasma HIV-1 RNA less than 50 c/mL using the FDA Snapshot algorithm [ Time Frame: At Weeks 24 and 48 ]
    Blood samples will be collected to assess the number of participants with plasma HIV-1 RNA less than 50 c/mL analyzed with FDA snapshot algorithm.
  • 3. Time to suppression of HIV-1 RNA less than 50 c/mL [ Time Frame: Up to Week 48 ]
    Participants reaching viral suppression HIV-1 RNA less than 50 c/mL will be analyzed at given time points
  • 4. Number of participants who change first line regimen of DTG + 3TC FDC due to Baseline laboratory or HIV-1 resistance mutation results [ Time Frame: Up to Week 48 ]
    Participants who change the first line regimen of DTG + 3TC FDC due to Baseline laboratory or HIV-1 resistance mutation results will be analyzed at given time points
  • 5. Number of participants with treatment-emergent genotypic resistance to DTG and/or 3TC, or any other ART if treatment is modified, in participants meeting confirmed virologic failure criteria [ Time Frame: Up to Week 52 ]
    Blood samples will be collected for genotypic and phenotypic analyses at given time point. These may be analyzed by Monogram Biosciences using, but not limited to, their Standard PhenoSense and GenoSure testing methods for protease (PRO), reverse transcriptase (RT), and integrase assays. This assessment will be performed for participants meeting virologic failure criteria
  • 6. Number of participants with treatment-emergent phenotypic resistance to DTG and/or 3TC, or any other ART treatment, modified, in participants meeting confirmed virologic failure criteria [ Time Frame: Up to Week 48 ]
    Blood samples will be collected for genotypic and phenotypic analyses at given time point. This will be analyzed by Monogram Biosciences using, but not limited to, their Standard PhenoSense and GenoSure testing methods for protease (PRO), reverse transcriptase (RT), and integrase assays. This assessment will performed for participants with meeting confirmed virologic failure criteria
  • 7. Number of participants with adverse events (AEs) [ Time Frame: Up to Week 52 ]
    An AE is any untoward medical occurrence in a study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
  • 8. Severity of AEs [ Time Frame: Up to Week 52 ]
    Assessment of severity and intensity for each AE will be reported during the study. Intensity will be performed based on the division of acquired immune deficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric AEs (Division of AIDS [DAIDS] AE Grading Table)
  • 9. Number of participants with abnormal hematology parameters [ Time Frame: Up to Week 48 ]
    Blood sample will be collected to measure laboratory parameters such as platelet count, red blood cells (RBC) count, white blood cells (WBC) count (absolute), haemoglobin (Hb), hematocrit, mean corpuscular volume (MCV), mean corpuscular Hb (MCH), neutrophils, lymphocytes, monocytes, eosinophils, basophils
  • 10. Number of participants with abnormal chemistry parameters [ Time Frame: Up to Week 48 ]
    Blood sample will be collected to measure laboratory parameters such as blood urea nitrogen (BUN), creatinine, glucose, sodium, calcium, potassium chloride, total carbon dioxide (CO2), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, phosphate, protein, total bilirubin, direct bilirubin, albumin, glomerular Filtration rate (GFR)/creatinine clearance, cystatin-C
  • 11. Number of participants with abnormal urinalysis parameters [ Time Frame: Up to Week 48 ]
    Urine sample will be collected to measure urinalysis parameters such as specific gravity, power of hydrogen (pH), glucose, protein, blood and ketones by dipstick (with microscopic examination if blood or protein is abnormal), urine albumin/creatinine ratio, urine protein/creatinine ratio
  • 12. Number of participants who discontinued the treatment due to AEs [ Time Frame: Up to Week 48 ]
    Number of participants who will discontinue the treatment due to AEs will be analyzed
  • 13. Number of participants who discontinued the treatment due to drug-related AEs [ Time Frame: Up to Week 48 ]
    Number of participants who will discontinue the treatment due to drug-related AEs will be analyzed
  • 14. Change from Baseline in CD4+ cell counts [ Time Frame: Baseline (Day 1), Week 24 and 48 ]
    Blood samples will be collected at indicated time points
  • 15. Change from Baseline in CD4+/ cluster of differentiation 8 (CD8)+ ratio [ Time Frame: Baseline (Day 1), Week 24 and 48 ]
    Blood samples will be collected at indicated time points
  • 16. Number of participants who complete their visit [ Time Frame: At Weeks 24 and 48 ]
    Number of participants who will complete their visit at given time point will be analyzed
  • 17. Number of participants who complete their visit with HIV-1 RNA less than 200 c/mL [ Time Frame: At Weeks 24 and 48 ]
    Number of participants who complete their visit with HIV-1 RNA less than 200 c/mL will be analyzed at given time points
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts
Locations
Show 17 Study Locations
Sponsors and Collaborators

ViiV Healthcare

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare

More Information
  • Responsible Party: ViiV Healthcare
  • ClinicalTrials.gov Identifier: NCT03945981 History of Changes
  • Other Study ID Numbers: 212355
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: October 2, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR)
  • Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
  • Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
  • URL: http://clinicalstudydatarequest.com
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by ViiV Healthcare: GSK3515864, dolutegravir, Dovato, lamivudine, 3TC, HIV-1, Test and Treat
  • Additional relevant MeSH terms: HIV Infections