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A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults (DYNAMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04900038
Recruitment Status : Active, not recruiting
First Posted : May 25, 2021
Last Update Posted : January 25, 2023
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
ViiV Healthcare

Tracking Information
First Submitted Date  ICMJE May 19, 2021
First Posted Date  ICMJE May 25, 2021
Last Update Posted Date January 25, 2023
Actual Study Start Date  ICMJE August 18, 2021
Actual Primary Completion Date November 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
Percentage (%) of participants with plasma HIV-1 ribonucleic acid (RNA) less than(<)50 copies per milliliter (c/mL) at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm [ Time Frame: At Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
  • Percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 using the FDA snapshot algorithm [ Time Frame: At Week 48 ]
  • Absolute values of HIV-1 RNA through Weeks 24 and 48 [ Time Frame: Through Weeks 24 and 48 ]
  • Change from Baseline in HIV-1 RNA through Weeks 24 and 48 [ Time Frame: Baseline (Day 1), through Weeks 24 and 48 ]
  • Absolute values of cluster of differentiation 4+ (CD4+) T-cell counts through Weeks 24 and 48 [ Time Frame: Through Weeks 24 and 48 ]
  • Change from Baseline in CD4+ T-cell counts through Weeks 24 and 48 [ Time Frame: Baseline (Day 1), through Weeks 24 and 48 ]
  • Number of participants reporting serious adverse events (SAEs), Deaths, adverse events leading to discontinuation (AELD) and adverse events of special interest (AESIs) through Weeks 24 and 48 [ Time Frame: Through Weeks 24 and 48 ]
  • Number of participants who develop genotypic resistance through Week 48 [ Time Frame: Up to Week 48 ]
  • Number of participants who develop phenotypic resistance through Week 48 [ Time Frame: Up to Week 48 ]
  • Trough concentration (Ctrough) of GSK3640254 at Weeks 2, 4, 8, 12, 24 and 48 [ Time Frame: At Weeks 2, 4, 8, 12, 24 and 48 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults
Official Title  ICMJE A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve Adults
Brief Summary The purpose of this study is to evaluate the efficacy of GSK3640254 + DTG relative to lamivudine (3TC) + DTG in treatment-naïve adult participants living with human immunodeficiency virus (HIV)-1. The participants will be randomized to one of the three doses of blinded GSK3640254 (100, 150, or 200 milligrams [mgs]) or a reference arm of blinded 3TC-each in combination with open label DTG.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a randomized, parallel-group study.
Masking: Double (Participant, Investigator)
Masking Description:
The dose level of GSK3640254 in each of the treatment arms containing GSK3640254 will be blinded to the research participants and all study personnel during the study through the Week 24 primary endpoint.
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: GSK3640254
    GSK3640254 will be available as 25 mg or 100 mg tablets to be administered orally
  • Drug: Dolutegravir
    DTG will be available as 50 mg tablets, to be administered orally
  • Drug: Lamivudine capsules
    3TC will be available as 300 mg capsules, to be administered orally as a blinded treatment
  • Drug: Lamivudine tablets
    3TC will be available as 300 mg tablets, to be administered orally as an unblinded treatment
Study Arms  ICMJE
  • Experimental: Blinded GSK3640254 100 mg + unblinded DTG
    Participants will receive blinded GSK3640254 100 mg + unblinded DTG through at least Week 24 (double blind phase). The participants will receive optimal dose of GSK3640254 after the optimal dose has been selected by study 208379. The participants will receive optimal dose of unblinded GSK3640254 and unblinded DTG once both conditions are met: GSK3640254 optimal dose has been selected AND the study has reached Week 24 primary endpoint.
    Interventions:
    • Drug: GSK3640254
    • Drug: Dolutegravir
  • Experimental: Blinded GSK3640254 150 mg + unblinded DTG
    Participants will receive blinded GSK3640254 150 mg + unblinded DTG through at least Week 24 (double blind phase). The participants will receive optimal dose of GSK3640254 after the optimal dose has been selected by study 208379. The participants will receive optimal dose of unblinded GSK3640254 and unblinded DTG once both conditions are met: GSK3640254 optimal dose has been selected AND the study has reached Week 24 primary endpoint.
    Interventions:
    • Drug: GSK3640254
    • Drug: Dolutegravir
  • Experimental: Blinded GSK3640254 200 mg + unblinded DTG
    Participants will receive blinded GSK3640254 200 mg + unblinded DTG through at least Week 24 (double blind phase). The participants will receive optimal dose of GSK3640254 after the optimal dose has been selected by study 208379. The participants will receive optimal dose of unblinded GSK3640254 and unblinded DTG once both conditions are met: GSK3640254 optimal dose has been selected AND the study has reached Week 24 primary endpoint.
    Interventions:
    • Drug: GSK3640254
    • Drug: Dolutegravir
  • Active Comparator: Blinded 3TC 300 mg + unblinded DTG
    Participants will receive blinded 3TC 300 mg capsules + unblinded DTG through at least Week 24 (double blind phase). The participants will receive unblinded 3TC 300 mg tablets + unblinded DTG once both conditions are met: GSK3640254 optimal dose has been selected by study 208379 AND the study has reached Week 24 primary endpoint.
    Interventions:
    • Drug: Dolutegravir
    • Drug: Lamivudine capsules
    • Drug: Lamivudine tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 1, 2022)
85
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2021)
80
Estimated Study Completion Date  ICMJE June 7, 2023
Actual Primary Completion Date November 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Treatment-naive, defined as no anti-retrovirals (ARVs) (in combination or monotherapy) received after a known diagnosis of HIV-1 infection.
  • Documented HIV infection and Screening plasma HIV-1 RNA greater than or equal to (>=)1000 c/mL.
  • Screening CD4+ T-cell count >=250 cells per millimeter^3 (cells/cubic millimeter).
  • Body weight >=50.0 kilograms (kg) (110 pounds [lbs.]) for men and >=45.0 kg (99 lbs.) for women and body mass index (BMI) >18.5 kilograms per meter^2 (kg/meter square). Calculations will utilize sex assigned at birth.

Exclusion Criteria:

  • Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi's sarcoma not requiring systemic therapy.
  • Presence of primary HIV infection, evidenced by acute retroviral syndrome (example [e.g.], fever, malaise, fatigue, etc.) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion.
  • Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment);
  • History of ongoing or clinically relevant hepatitis within the previous 6 months.
  • Any history of significant underlying psychiatric disorder.
  • Any history of major depressive disorder with or without suicidal features, or anxiety disorders, that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (>6 months) outpatient treatment.
  • A pre-existing condition, in the opinion of the Investigator or Medical Monitor, that could interfere with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease [GERD], gastric ulcers, gastritis, inflammatory bowel disease), hepatic and/or renal function, or with the absorption, metabolism, and/or excretion of the study interventions or render the participant unable to take oral study treatment.
  • Familial or personal history of long QT syndrome or sudden cardiac death.
  • Active treatment for a viral infection other than HIV-1, such as Hepatitis B, with an agent that is active against HIV-1 (were known to be infected with HIV-1 after treatment for Hepatitis B was completed).
  • Participants who require concomitant medications known to be associated with a prolonged corrected QT (QTc) interval.
  • Exposure to an experimental drug, human blood product, monoclonal antibody, or vaccine (which does not have emergency, conditional, or standard market authorization) within 28 days prior to the first dose of study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   France,   Germany,   Italy,   Portugal,   Puerto Rico,   South Africa,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04900038
Other Study ID Numbers  ICMJE 212483
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data 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
Current Responsible Party ViiV Healthcare
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ViiV Healthcare
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Syneos Health
Investigators  ICMJE
Study Director: GSK Clinical Trials ViiV Healthcare
PRS Account ViiV Healthcare
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP