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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 pre-dose (day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called GSK3810109A to see if it can help people with HIV-1 who have not been treated before. The drug is expected to reduce the amount of virus in the body and support the immune system in fighting the infection.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
HIV Suppression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose (day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose (day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose (day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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

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

+10 more

Side effects data

From 2023 Phase 2 trial • 62 Patients • NCT04871113

13%

Tonsillar hypertrophy

13%

Hypertriglyceridaemia

13%

Fatigue

13%

Infusion site erythema

13%

Oropharyngeal gonococcal infection

13%

Pruritus

13%

Nasopharyngitis

13%

Pain in extremity

13%

Gastrointestinal pain

13%

COVID-19

13%

Blood creatine phosphokinase increased

13%

Migraine

13%

Abdominal pain

13%

Infusion site pain

13%

Lipase increased

13%

Dizziness

13%

Headache

13%

Hot flush

100%

80%

60%

40%

20%

Study treatment Arm

Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)

Part 1: GSK3810109A 280 mg IV

Part 2: GSK3810109A 700 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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups

Experimental Treatment

Group I: Standard of care (SOC) - GSK3810109A 40mg/kg IVExperimental Treatment1 Intervention

Participants 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.

Group II: SOC - GSK3810109A 700 mg SCExperimental Treatment1 Intervention

Participants 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.

Group III: SOC - GSK3810109A 700 mg IVExperimental Treatment1 Intervention

Participants 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.

Group IV: SOC - GSK3810109A 70 mg IVExperimental Treatment1 Intervention

Participants 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.

Group V: SOC - GSK3810109A 280 mg IVExperimental Treatment1 Intervention

Participants 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.

Group VI: Part 2: GSK3810109A 700 mg subcutaneously (SC)Experimental Treatment1 Intervention

Participants 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.

Group VII: Part 2: GSK3810109A 700 mg IVExperimental Treatment1 Intervention

Participants 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.

Group VIII: Part 2: GSK3810109A 70 mg IVExperimental Treatment1 Intervention

Participants 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.

Group IX: Part 1:GSK3810109A 40milligram(mg)/kilogram intravenously (IV)Experimental Treatment1 Intervention

Participants 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.

Group X: Part 1: GSK3810109A 280 mg IVExperimental Treatment1 Intervention

Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dolutegravir+lamivudine SOC regimen

2021

Completed Phase 2

~70

GSK3810109A

2021