VH3810109 for Human Immunodeficiency Virus Infection

GSK Investigational Site, Austin, TX
Human Immunodeficiency Virus InfectionVH3810109 - Biological
Eligibility
18 - 65
All Sexes

Study Summary

This trial will study the safety and tolerability of VH3810109 given by injection, either under the skin or into a vein. Participants will be given a single dose of the drug and will be monitored for side effects for 24 weeks.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Similar Trials

1
sotrovimab
1
NM26-2198 50 mg
1
Tirzepatide - Test

Study Objectives

12 Primary · 36 Secondary · Reporting Duration: Day 1, 2 and 7

Week 24
Change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and alkaline phosphatase (ALP) (International Units per liter)
Change from baseline in Glucose (fasting), BUN, Creatinine, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Change from baseline in Hematocrit (percentage)
Change from baseline in Hgb, albumin and total protein (grams per deciliter)
Change from baseline in Mean Corpuscle Hemoglobin (MCH) (picograms per cell)
Change from baseline in Mean Corpuscle Volume (MCV) (cubic microns)
Change from baseline in PR Interval, QRS Interval, QT Interval, and QT Interval corrected for heart rate using Fridericia's formula (QTcF)
Change from baseline in Platelets, WBC count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils (cells per microliter)
Change from baseline in Pulse Rate
Change from baseline in Red Blood Cell Count (RBC) (million cells per microliter)
Change from baseline in Respiratory Rate
Change from baseline in Sodium, Potassium, Calcium, Chloride and Carbon Dioxide (milliequivalents per liter)
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in Temperature
Change from baseline in differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (percentage)
Change from baseline in urine Specific Gravity (ratio)
Number of participants with presence of Glucose, Protein, Blood, Ketones, Bilirubin, Urobilinogen, Nitrite, Leukocyte Esterase in urine
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method
Day 1
Percentage of participants with post-injection pain assessment using NRS following VH3810109 IV administration
Pain
Percentage of participants with post-injection pain assessment using Numeric Rating Scale (NRS) following VH3810109 SC administration
Day 7
Number of participants with Individual item score assessing pain using PIN Questionnaire
Number of participants with change in dimension score "acceptance of ISRs" using Perception of Injection (PIN) Questionnaire
Percentage of participants reporting being bothered or affected by the pain and local reactions based on the PIN Questionnaire
Up to 7 days
Percentage of participants with ISRs following VH3810109 IV administration
Percentage of participants with injection site reactions (ISRs)
Percentage of participants with injection site reactions (ISRs) following VH3810109 SC administration
Up to Day 14
Duration of ISRs overall and by grade
Percentage of participants reporting ISRs overall and by grade
Up to Week 24
AUC from time zero to time t (AUC[0-t]) of VH3810109
Apparent terminal phase half-life (t1/2) of VH3810109
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC[0-inf]) of VH3810109
Maximum observed concentration (Cmax) of VH3810109
Part 1 and Part 2: AUC from time zero to time t (AUC[0-t]) of VH3810109
Part 1 and Part 2: Apparent terminal phase half-life (t1/2) of VH3810109
Part 1 and Part 2: Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC[0-inf]) of VH3810109
Part 1 and Part 2: Maximum observed concentration (Cmax) of VH3810109
Part 1 and Part 2: Time of maximum observed concentration (Tmax) of VH3810109
Percentage of participants serious adverse events (SAE)
Alanine Transaminase
Percentage of participants with Grade 2 to 4 elevated ALT/AST values following VH3810109 IV administration
Percentage of participants with Grade 2 to 4 elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) values following VH3810109 SC administration
Percentage of participants with SAE following VH3810109 IV administration
Percentage of participants with serious adverse events (SAE) following VH3810109 SC administration
Percentage of participants with ≥ Grade 2 AEs following IV administration of VH3810109
Percentage of participants with ≥ Grade 2 adverse events (AEs)
Percentage of participants with ≥ Grade 2 adverse events (AEs) following SC administration of VH3810109
Time of maximum observed concentration (Tmax) of VH3810109

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
sotrovimab
1
NM26-2198 50 mg
1
Tirzepatide - Test

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

VH3810109 + rHuPH20
1 of 3
Part 1: VH3810109 + rHuPH20
1 of 3
Part 2: VH3810109
1 of 3

Experimental Treatment

24 Total Participants · 3 Treatment Groups

Primary Treatment: VH3810109 · No Placebo Group · Phase 1

VH3810109 + rHuPH20Experimental Group · 2 Interventions: VH3810109, rHuPH20 · Intervention Types: Biological, Biological
Part 1: VH3810109 + rHuPH20Experimental Group · 2 Interventions: VH3810109, rHuPH20 · Intervention Types: Biological, Biological
Part 2: VH3810109
Biological
Experimental Group · 1 Intervention: VH3810109 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VH3810109
2022
Completed Phase 1
~30
rHuPH20
2008
Completed Phase 2
~620

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, 2 and 7

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
338 Previous Clinical Trials
462,393 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,573 Previous Clinical Trials
6,137,066 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Is this research focusing on participants aged 35 or older?

"To be eligible for this study, patients must fall within the age bracket of 18 to 65. Fortunately, there are many additional trials available for minors and senior citizens; 108 studies exist for those under 18 years old and 353 options for people over 65." - Anonymous Online Contributor

Unverified Answer

Might I be eligible to participate in this medical experiment?

"8 individuals living with HIV, aged between 18 and 65, are invited to participate in this research. To be suitable for inclusion, they must meet certain criteria regarding their health as determined by medical history assessment, physical examination tests and laboratory checks; plus having no pre-existing conditions listed in the study's protocol." - Anonymous Online Contributor

Unverified Answer

What potential adverse reactions may arise from utilization of VH3810109?

"Due to a paucity of data, VH3810109 scored 1 on our safety scale. As it is currently in Phase 1 trials, the efficacy and safety are only minimally supported by evidence." - Anonymous Online Contributor

Unverified Answer

Are there any open roles for participants within this exploration?

"Affirmative. According to information posted on clinicaltrials.gov, this research endeavour is currently seeking enrollees. The experiment was initially listed on February 23rd 2022 and underwent a recent edit on September 19th 2022. A total of 8 participants need to be recruited from 1 study site.." - Anonymous Online Contributor

Unverified Answer

How many participants are enrolled in this investigation?

"Confirmed. The clinicaltrials.gov registry reveals that recruitment for this study, which was first announced on February 23rd 2022, is underway. A total of 8 participants are being sought from one medical facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top