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112 Participants NeededMy employer runs this trial

VH4367310 for HIV Infection

Recruiting at 1 trial location
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: ViiV Healthcare

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 55, weighing at least 40 kg, with a BMI between 18 and 32. Participants must be able to give consent and agree to use contraception if required. Only those in good health can join.

Inclusion Criteria

Participants who are overtly healthy as determined by medical evaluation
I am male and will use contraception, or I am female and cannot become pregnant.
Body weight >=40 kg and BMI between 18 and 32 kg/m^2
See 2 more

Exclusion Criteria

I have not lost more than 500 mL of blood in the past 56 days.
Total bilirubin >1.5x ULN except participants with Gilbert's syndrome if direct bilirubin <=1.5x ULN
I have previously used CAB for PrEP or in a research study.
See 28 more

What Are the Treatments Tested in This Trial?

Interventions

  • VH4367310

Trial Overview

The study is testing single increasing doses of VH4367310 (a new form of cabotegravir) given by injection into the muscle, compared to a placebo. The main focus is on how the body processes the drug and its safety in healthy people.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: VH4367310 GroupExperimental Treatment1 Intervention
Group II: Placebo GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

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