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Monoclonal Antibodies

VH3810109 for Human Immunodeficiency Virus Infection (SPAN Trial)

Q: Might I be eligible to participate in this medical experiment?

<p>8 individuals living with <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>, 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.</p>

Phase 1

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 day 1, 2 and 7

Awards & highlights

SPAN Trial 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.

SPAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 2 and 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 2 and 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 2 and 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 ISRs following VH3810109 IV administration

+5 more

Secondary outcome measures

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)

+27 more

SPAN Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: VH3810109Experimental Treatment1 Intervention

Healthy participants will receive a single IV dose of VH3810109 injection.

Group II: Part 1: VH3810109 + rHuPH20Experimental Treatment2 Interventions

Healthy participants will receive a single SC dose of VH3810109 injection with rHuPH20.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VH3810109

2022

Completed Phase 1

~30

rHuPH20

2008

Completed Phase 2

~650

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ViiV HealthcareLead Sponsor

360 Previous Clinical Trials

468,555 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorViiV Healthcare

3,595 Previous Clinical Trials

6,143,906 Total Patients Enrolled

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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.."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

2022. "A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05291520.