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Virus Therapy

GSK3810109A for Human Immunodeficiency Virus Infection

Phase 2
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights

Study Summary

This trial is testing a new antiviral drug, GSK3810109A, to see if it is safe and effective in HIV-1 infected adults who have not taken any other HIV treatment before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase
Number of Participants With Adverse Events (AEs) - Monotherapy Phase
Number of Participants With Grade 2-4 Injection Site Reactions (ISR) - Monotherapy Phase
+2 more
Secondary outcome measures
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) T Cell Counts (Cells Per Cubic Millimeters)
Area Under the Plasma Concentration-time Curve From Time Zero to the Day 14 (AUC [0-14]) of GSK3810109A
Change From Baseline in CD4+ T Cell Counts (Cells Per Cubic Millimeters)
+6 more

Side effects data

From 2023 Phase 2 trial • 63 Patients • NCT04871113
13%
Migraine
13%
Hot flush
13%
Pruritus
13%
Fatigue
13%
Pain in extremity
13%
Dizziness
13%
Tonsillar hypertrophy
13%
Infusion site pain
13%
COVID-19
13%
Nasopharyngitis
13%
Blood creatine phosphokinase increased
13%
Headache
13%
Hypertriglyceridaemia
13%
Abdominal pain
13%
Gastrointestinal pain
13%
Infusion site erythema
13%
Lipase increased
13%
Oropharyngeal gonococcal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)
Part 2: GSK3810109A 700 mg IV
Part 1: GSK3810109A 280 mg IV
Part 2: GSK3810109A 70 mg IV
Part 2: GSK3810109A 700 mg Subcutaneously (SC)
SOC - GSK3810109A 40mg/kg IV
SOC - GSK3810109A 280 mg IV
SOC - GSK3810109A 700 mg IV
SOC - GSK3810109A 70 mg IV
SOC - GSK3810109A 700 mg SC

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2: Participants receiving GSK3810109A (Cohort 5)Experimental Treatment1 Intervention
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.
Group II: Part 2: Participants receiving GSK3810109A (Cohort 4)Experimental Treatment1 Intervention
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
Group III: Part 2: Participants receiving GSK3810109A (Cohort 3)Experimental Treatment1 Intervention
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.
Group IV: Part 1: Participants receiving GSK3810109A 40 mg/kg (Cohort 1)Experimental Treatment1 Intervention
Participants will be administered GSK3810109A as a single IV infusion of 40 mg/kg dose in Part 1.
Group V: Part 1: Participants receiving GSK3810109A 280 mg (Cohort 2)Experimental Treatment1 Intervention
Participants will be administered GSK3810109A as a single IV infusion of 280 mg dose in Part 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3810109A
2021
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
359 Previous Clinical Trials
468,585 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,593 Previous Clinical Trials
6,139,876 Total Patients Enrolled

Media Library

GSK3810109A (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04871113 — Phase 2
Human Immunodeficiency Virus Infection Research Study Groups: Part 2: Participants receiving GSK3810109A (Cohort 4), Part 2: Participants receiving GSK3810109A (Cohort 5), Part 1: Participants receiving GSK3810109A 40 mg/kg (Cohort 1), Part 1: Participants receiving GSK3810109A 280 mg (Cohort 2), Part 2: Participants receiving GSK3810109A (Cohort 3)
Human Immunodeficiency Virus Infection Clinical Trial 2023: GSK3810109A Highlights & Side Effects. Trial Name: NCT04871113 — Phase 2
GSK3810109A (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04871113 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility criteria for this study limited to individuals under 35 years of age?

"This research study is accepting patients who are at least 18 years of age and no more than 65 years old."

Answered by AI

How many healthcare facilities are partaking in this experiment?

"The trial is currently taking place in 15 different sites, with the most prominent being Birmingham, Long Beach and Indianapolis. To reduce any travelling hassles, we recommend you select a site that's closest to your current residence."

Answered by AI

Has GSK3810109A been given regulatory clearance by the FDA?

"Based on our internal analysis, the safety profile GSK3810109A is rated as a 2. This rating reflects its current status in Phase 2 trials where only limited data supports safety but no evidence of efficacy has been documented yet."

Answered by AI

Is it feasible for me to join this medical study?

"This medical trial is searching for up to 44 participants living with HIV, aged 18-65. Notably, the criteria spans gender and sexual practices: men and women of childbearing potential must have negative pregnancy tests prior to participating and all individuals should be counselled on safer sexual practices. Additionally, only antiretroviral naïve patients who weigh between 50kg - 115kg are eligible."

Answered by AI

Is enrollment open for this clinical experiment at the moment?

"The hosting website, clinicaltrials.gov states that this trial is no longer seeking participants having been first posted on June 22nd 2021 and last updated October 25th 2022. Despite the inactivity of this particular study, there are still 484 other trials attempting to enroll patients at present."

Answered by AI

Who else is applying?

What state do they live in?
California
Alabama
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
GSK Investigational Site
~17 spots leftby Mar 2025