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A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04871113
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults. Participants will receive a single dose of GSK3810109A administered either intravenously (IV) or subcutaneously (SC). The study includes a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: GSK3810109A Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The is a sequential treatment, two-part study which will include a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.
Masking: None (Open Label)
Masking Description: This is an open-label study
Primary Purpose: Treatment
Official Title: A Phase 2a Multicentre, Randomized, Open-Label, Two-Part Adaptive Design Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A, an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody in Antiretroviral-naïve HIV-1-Infected Adults
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : December 22, 2022
Estimated Study Completion Date : November 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Part 1: Participants receiving GSK3810109A 40 mg/kg (Cohort 1)
Participants will be administered GSK3810109A as a single IV infusion of 40 mg/kg dose in Part 1.
Biological: GSK3810109A
GSK3810109A will be available as sterile aqueous solution.

Experimental: Part 1: Participants receiving GSK3810109A 280 mg (Cohort 2)
Participants will be administered GSK3810109A as a single IV infusion of 280 mg dose in Part 1.
Biological: GSK3810109A
GSK3810109A will be available as sterile aqueous solution.

Experimental: Part 2: Participants receiving GSK3810109A (Cohort 3)
Participants will be administered GSK3810109A as a single IV infusion or SC injection and will include dose level determined based on the data of Part 1.
Biological: GSK3810109A
GSK3810109A will be available as sterile aqueous solution.

Experimental: Part 2: Participants receiving GSK3810109A (Cohort 4)
Participants will be administered GSK3810109A as a single IV infusion or SC injection and will include dose level determined based on the data of Part 1
Biological: GSK3810109A
GSK3810109A will be available as sterile aqueous solution.

Experimental: Part 2: Participants receiving GSK3810109A (Cohort 5)
Participants will be administered GSK3810109A as a single IV infusion or SC injection and will include dose level determined based on the data of Part 1.
Biological: GSK3810109A
GSK3810109A will be available as sterile aqueous solution.




Primary Outcome Measures :
  1. Maximum change from Baseline in plasma HIV-1 ribonucleic acid (RNA) levels (copies/milliliter) [ Time Frame: Baseline and up to Day 84 ]
  2. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Week 60 ]
  3. Number of participants with Grade 2-4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) abnormality [ Time Frame: Up to Week 60 ]
  4. Number of participants with treatment-emergent abnormal electrocardiogram (ECG) findings [ Time Frame: Up to Day 84 ]
  5. Number of participants with Grade 2-4 injection site reactions (ISR) [ Time Frame: Up to Day 84 ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC [0-t]) of GSK3810109A [ Time Frame: Up to Week 60 ]
  2. Maximum observed concentration (Cmax) of GSK3810109A [ Time Frame: Up to Week 60 ]
  3. Time to reach maximum observed plasma concentration (Tmax) of GSK3810109A [ Time Frame: Up to Week 60 ]
  4. Plasma concentration of GSK3810109A [ Time Frame: Up to Week 60 ]
  5. Change from Baseline in Plasma HIV-1 RNA in relation to Cmax [ Time Frame: Baseline and up to Week 60 ]
  6. Change from Baseline in Plasma HIV-1 RNA in relation to AUC [ Time Frame: Baseline and up to Week 60 ]
  7. Change from Baseline in cluster of differentiation 4 plus (CD4+) T cell counts (cells per cubic millimeters) [ Time Frame: Baseline and up to Week 60 ]
  8. Absolute values of CD4+ T cell counts [ Time Frame: Up to Week 60 ]
  9. Number of participants with positive anti-drug antibodies (ADAs) against GSK3810109A [ Time Frame: Up to Week 60 ]
  10. Titers of ADAs against GSK3810109A [ Time Frame: Up to Week 60 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Participants must have HIV-1 infection within 45 days of the Screening Visit: Plasma HIV-1 RNA greater than or equal to (>=) 5000 copies/mL (c/mL).
  • Confirmed screening CD4+ T-cell count >= 350 cells per cubic millimeter (cells/mm3).
  • Antiretroviral naïve: No Antiretroviral therapy (ARTs) (in combination or monotherapy) received after the diagnosis of HIV-1 infection.
  • Body weight >= 50 kg to less than or equal to (<=) 115 kg.
  • Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All participants participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g. male condom) and on the risk of HIV transmission to an uninfected partner; a. Participants who are female at birth are eligible to participate if at least one of the following conditions applies: Not Pregnant or breastfeeding and at least one of the following conditions applies: Is not a participant of childbearing potential (POCBP). OR Is a POCBP and using an acceptable contraceptive method during the intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) on Day 1, prior to the first dose of study intervention. If a urine test cannot be confirmed as negative (example [e.g.], an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
  • Corrected QT interval (QTc) Interval <= 450 milliseconds (msec)
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Participants with primary HIV infection, evidenced by acute retroviral syndrome (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.
  • Participants who are pregnant, breastfeeding, plan to become pregnant or breastfeed during the study.
  • The participant has an underlying skin disease or disorder (example i.e. infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that would interfere with assessment of injection sites.
  • Known history of cirrhosis with or without viral hepatitis co-infection.
  • History of clinically relevant hepatitis within last 6 months.
  • Evidence of Hepatitis B virus (HBV) infection based on the results of testing at screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: Participants positive for HBsAg are excluded; Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and negative for HBV DNA are not excluded.
  • Participants with Hepatitis C co-infection.
  • Untreated syphilis infection (positive rapid plasma reagin [RPR] at screening) without documentation of treatment. Participants who are one month post completed treatment are eligible if recruitment is open.

Rescreening is allowed after treatment.

  • Prior receipt of licensed or investigational monoclonal antibody.
  • Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy.
  • Known or suspected moderate or severe hepatic impairment (Class C as determined by Child-Pugh Classification) coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease at the discretion of the investigator.
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, 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 prior to randomization.
  • 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 completion of the study.
  • Participants who in the investigator's judgment, pose a significant suicidality risk. Participants' history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
  • History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
  • Any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs, combination ART or render the participant unable to take oral medication.
  • Participants with a positive Corona Virus Disease 2019 (COVID-19) test at Screening. Participants with known COVID-19 positive contacts within the past 14 days, or with symptoms suggestive of active COVID-19 (fever, cough, myalgias, shortness of breath, loss of taste or smell), should be excluded. Participants who remain symptom-free for at least 14 days after a COVID-19 exposure are allowed.
  • Has received any HIV-1 immunotherapeutic vaccine or prophylactic vaccine.
  • 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 dose of IP.
  • Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
  • Participant enrolled in a prior or concurrent clinical study that includes a drug intervention within the last 30 days.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's inclusion in the study of an investigational compound.
  • Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result.
  • ALT >= 3 times the upper limit of normal (ULN).
  • Creatinine clearance of <50 mL/minute/1.73 meter^2) via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method.
  • The participant has a tattoo or other dermatological condition overlying potential injection sites which may interfere with interpretation of injection site reactions or administration of GSK3810109A.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871113


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Alabama
GSK Investigational Site Recruiting
Birmingham, Alabama, United States, 35294
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sonya Heath         
United States, California
GSK Investigational Site Recruiting
Long Beach, California, United States, 90813
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Stefan Schneider         
GSK Investigational Site Recruiting
Los Angeles, California, United States, 90027
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: William J. Towner         
GSK Investigational Site Recruiting
Los Angeles, California, United States, 90036
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Peter J Ruane         
United States, Florida
GSK Investigational Site Recruiting
Orlando, Florida, United States, 32803
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Charlotte-Paige Rolle         
GSK Investigational Site Recruiting
Tampa, Florida, United States, 33606
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Beata Casanas         
United States, Indiana
GSK Investigational Site Recruiting
Indianapolis, Indiana, United States, 46202
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Samir Gupta         
United States, Michigan
GSK Investigational Site Recruiting
Berkley, Michigan, United States, 48072
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Paul Benson         
United States, New York
GSK Investigational Site Recruiting
Manhasset, New York, United States, 11030
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Joseph McGowan         
United States, North Carolina
GSK Investigational Site Recruiting
Durham, North Carolina, United States, 27710
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mehri S McKellar         
United States, South Carolina
GSK Investigational Site Recruiting
Charleston, South Carolina, United States, 29425
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Eric G Meissner         
United States, Texas
GSK Investigational Site Recruiting
Dallas, Texas, United States, 75246
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Christopher J. Bettacchi         
Argentina
GSK Investigational Site Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Marisa Sanchez         
GSK Investigational Site Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AGC
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sebastian Nuñez         
GSK Investigational Site Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1405CKC
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ezequiel Cordova         
GSK Investigational Site Recruiting
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1202ABB
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Pedro Cahn         
GSK Investigational Site Recruiting
Mar del Plata, Buenos Aires, Argentina, 7600
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Alejandro Ferro         
GSK Investigational Site Recruiting
Rosario, Santa Fe, Argentina, S2000PBJ
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sergio Lupo         
GSK Investigational Site Recruiting
Buenos Aires, Argentina, 1023
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Veronica Lacal Ridilenir         
GSK Investigational Site Recruiting
San Juan, Argentina, 5400
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Rosa Veronica Contreras Paez         
Brazil
GSK Investigational Site Recruiting
Rio de Janeiro, Brazil, 21045-900
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Beatriz Gilda Jegerhorn Grinsztejn         
GSK Investigational Site Recruiting
São Paulo, Brazil, 05403-010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Esper Georges Kallas         
Canada, Ontario
GSK Investigational Site Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jonathan B Angel         
GSK Investigational Site Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sharon L. Walmsley         
Canada, Quebec
GSK Investigational Site Recruiting
Montreal, Quebec, Canada, H2L 4E9
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Benoit Trottier         
GSK Investigational Site Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Marina B Klein         
Canada, Saskatchewan
GSK Investigational Site Recruiting
Regina, Saskatchewan, Canada, S4P 0W5
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Alexander Wong         
Mexico
GSK Investigational Site Recruiting
Monterrey, Nuevo León, Mexico, 66278
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Reynaldo Lara-Medrano         
GSK Investigational Site Recruiting
Merida, Mexico, 97000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Carlos Antonio Cabrera-May         
Sponsors and Collaborators
ViiV Healthcare
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT04871113    
Other Study ID Numbers: 207959
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
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, 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ViiV Healthcare:
Antiretroviral-naïve
Broadly neutralizing antibody
GSK3810109A
HIV
N6LS
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases