AzTrials
AzTrials

HIV InfectionsPhase 2NCT04871113

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

A Phase 2 study testing GSK3810109A and Dolutegravir+lamivudine SOC regimen in people with HIV Infections, run by ViiV Healthcare at 24 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV Infections
What is being tested?
GSK3810109A and Dolutegravir+lamivudine SOC regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
24 sitesin 6 countries
Study dates
22 Jun 2021to 21 Sep 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.

Trial locations and contacts

24 sites in 6 countries.

24 sites in 6 countries

Argentina8 sites

  • GSK Investigational Site

    Buenos Aires, 1023

  • GSK Investigational Site

    Buenos Aires, C1181ACH

  • GSK Investigational Site

    Buenos Aires, C1202ABB

  • GSK Investigational Site

    Buenos Aires, C1425AGC

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1405CKC

  • GSK Investigational Site

    Mar del Plata, 7600

  • GSK Investigational Site

    Rosario, S2000PBJ

  • GSK Investigational Site

    San Juan, 5400

Other trials in Argentina

United States7 sites

  • GSK Investigational Site

    Berkley, Michigan, 48072

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Los Angeles, California, 90036

  • GSK Investigational Site

    Manhasset, New York, 11030

  • GSK Investigational Site

    Orlando, Florida, 32803

Other trials in United States

Canada4 sites

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Regina, Saskatchewan, S4P 0W5

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Brazil2 sites

  • GSK Investigational Site

    Rio de Janeiro, 21045-900

  • GSK Investigational Site

    São Paulo, 05403-010

Other trials in Brazil

Mexico2 sites

  • GSK Investigational Site

    Mérida, 97000

  • GSK Investigational Site

    Monterrey, 66278

Other trials in Mexico

Peru1 site

  • GSK Investigational Site

    Lima, Lima 4

Other trials in Peru

About this study

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

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.

Conditions
HIV Infections
Being tested
GSK3810109A, Dolutegravir+lamivudine SOC regimen
Keywords
Antiretroviral-naïve, Broadly neutralizing antibody, GSK3810109A, HIV, N6LS
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK3810109ABiological

    GSK3810109A available as sterile aqueous solution.

  • Dolutegravir+lamivudine SOC regimenBiological

    Dolutegravir+lamivudine regimen administered in consistence with investigator input and local guidelines

Study groups in NCT04871113
Study groupRoleWhat they receive
Part 1:GSK3810109A 40milligram(mg)/kilogram intravenously (IV)ExperimentalParticipants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.
Receives: Biological: GSK3810109A
Part 1: GSK3810109A 280 mg IVExperimentalParticipants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.
Receives: Biological: GSK3810109A
Part 2: GSK3810109A 700 mg IVExperimentalParticipants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Receives: Biological: GSK3810109A
Part 2: GSK3810109A 70 mg IVExperimentalParticipants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.
Receives: Biological: GSK3810109A
Part 2: GSK3810109A 700 mg subcutaneously (SC)ExperimentalParticipants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Receives: Biological: GSK3810109A
Standard of care (SOC) - GSK3810109A 40mg/kg IVExperimentalParticipants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Receives: Biological: Dolutegravir+lamivudine SOC regimen
SOC - GSK3810109A 280 mg IVExperimentalParticipants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Receives: Biological: Dolutegravir+lamivudine SOC regimen
SOC - GSK3810109A 700 mg IVExperimentalParticipants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Receives: Biological: Dolutegravir+lamivudine SOC regimen
SOC - GSK3810109A 70 mg IVExperimentalParticipants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Receives: Biological: Dolutegravir+lamivudine SOC regimen
SOC - GSK3810109A 700 mg SCExperimentalParticipants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Receives: Biological: Dolutegravir+lamivudine SOC regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase

    Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum decline from baseline in plasma HIV-1 RNA were measured in participants. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase

  2. Number of Participants With Adverse Events (AEs) - Monotherapy Phase

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: Up to Day 84 or end of Monotherapy Phase

  3. Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase

    Blood samples were collected for the analysis of ALT and AST parameters. The parameters ALT and AST were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data of number of participants with 2-4 grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase

  4. Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Findings - Monotherapy Phase

    A 12-lead ECG were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. ECG findings were categorized as normal, abnormal clinically significant (CS) and abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal (CS and NCS) ECG findings are presented. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: Up to Day 84 or end of Monotherapy Phase

  5. Number of Participants With Grade 2-4 Injection Site Reactions (ISR) - Monotherapy Phase

    Number of participants with grade 2-4 injection site reactions are presented. The ISR were graded using the Division of Acquired immunodeficiency syndrome (DAIDS) criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates more severe condition. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: Up to Day 84 or end of Monotherapy Phase

Secondary outcomes (13)

  1. Area Under the Plasma Concentration-time Curve From Time Zero to the Day 14 (AUC [0-14]) of GSK3810109A - Monotherapy Phase

    Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3810109A.

    Measured: Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

  2. Maximum Observed Plasma Concentration (Cmax) of GSK3810109A - Monotherapy Phase

    Cmax is defined as maximum observed concentration of GSK3810109A.

    Measured: Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of GSK3810109A - Monotherapy Phase

    Tmax is defined as time to reach Cmax

    Measured: Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

  4. Plasma Concentration at Day 14 (C14) of GSK3810109A - Monotherapy Phase

    Blood samples were collected at indicated time point for pharmacokinetic analysis of GSK3810109A.

    Measured: At Day 14

  5. Change From Baseline in Log10 Plasma HIV-1 RNA Relative to Cmax - Monotherapy Phase

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. Statistical analysis for relationship between PK parameter (Cmax) and PD measure (change from baseline in logarithm to base 10 (log10) values for plasma HIV-1 RNA) were explored using an Emax non-linear model. The model parameters estimated included: maximum response (Emax), PK parameter value that attains 50 percent (%) of the maximal effect (EC50) and residual variability (s2e). End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase

  6. Absolute Values of Cluster of Differentiation 4 Plus (CD4+) and CD8+ T Cell Counts - Monotherapy Phase

    Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: From Day 1 (Baseline) and up to Day 84 or end of Monotherapy Phase

  7. Absolute Values of CD4+ and CD8+ T Cell Counts - SOC Phase

    Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry.

    Measured: Up to Week 48 (SOC Phase)

  8. Change From Baseline in CD4+ and CD8+ T Cell Counts - Monotherapy Phase

    Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: Up to Day 84 or end of Monotherapy Phase (compared with baseline [Day 1])

  9. Change From Baseline in CD4+ and CD8+ T Cell Counts - SOC Phase

    Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry.

    Measured: Up to Week 48 (SOC Phase)

  10. Number of Participants With Positive Anti-drug Antibodies (ADAs) Against GSK3810109A - Monotherapy Phase

    Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: At Day 1 and Day 84 or end of Monotherapy Phase

  11. Number of Participants With Positive ADAs Against GSK3810109A - SOC Phase

    Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays.

    Measured: At Week 48 (SOC Phase)

  12. Titers of Positive ADAs Against GSK3810109A - Monotherapy Phase

    Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

    Measured: At Day 84 or end of Monotherapy Phase

  13. Titers of Positive ADAs Against GSK3810109A - SOC Phase

    Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays.

    Measured: At Week 48 (SOC Phase)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2021
  2. Study start22 Jun 2021
  3. Primary completion27 Oct 2022
  4. Study completion21 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
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)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04871113
Sponsor's protocol ID
207959
Status last verified
Sep 2024
First submitted
28 Apr 2021
Last updated
15 Oct 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.

Publications

  • Leone PA, Ferro A, Rolle CP, Lupo S, McGowan J, Klein M, Cahn P, Benson P, Griesel R, Warwick-Sanders M, Sanchez M, D'Agostino R, Bettacchi C, Schneider S, Wannamaker P, Dorey D, Wilches V, Gartland M, Brown K, Gandhi Y, Donatti C, Losos J. VH3810109 Efficacy, Safety, Pharmacokinetics, and Incidence of Antidrug Antibodies in Adults With HIV-1 Naive to Antiretroviral Therapy: BANNER Study Results. J Infect Dis. 2025 Dec 20;232(6):e1022-e1032. doi: 10.1093/infdis/jiaf450.

    PubMed 40892985

  • Leone PA, Losos J, Wannamaker P, D'Agostino R, Warwick-Sanders M, Ghita GL, Wilches V, Donatti C, Brown K, Gandhi Y. VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0025825. doi: 10.1128/aac.00258-25. Epub 2025 Jul 23.

    PubMed 40698814

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK3810109A and Dolutegravir+lamivudine SOC regimen in people with HIV Infections, run by ViiV Healthcare at 24 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Argentina, United States, Canada, Brazil, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase (time frame: Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04871113, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in