102 Participants Needed

VH4527079 for HIV

Recruiting at 1 trial location
EG
UG
Overseen ByUS GSK Clinical Trials Call Center
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: ViiV Healthcare
Must be taking: INSTI-based antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called VH4527079 for people with HIV. Researchers are exploring how the body processes the drug when administered in different doses and methods, such as through an IV or injection. They seek healthy volunteers and individuals with HIV who have maintained stability on HIV medication without treatment failures. Participants should be in good health, with their HIV well-managed on current medication. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that participants should not use over-the-counter or prescription medications, including herbal ones, within 7 days before the study. If you are on medications that prolong QTc or are protocol-prohibited, you may need to switch to an alternative.

Is there any evidence suggesting that VH4527079 is likely to be safe for humans?

Research has shown that VH4527079 is in the early stages of testing to determine its safety. Limited information exists on how well people tolerate it. In this first-phase trial, the primary goal is to assess safety and identify any side effects. Early studies often begin with small doses to observe the body's response.

Since VH4527079 is still under investigation, detailed safety results are not yet available. Phase one trials typically examine side effects in a small group of healthy individuals. Participation could contribute to understanding the safety of this treatment for others.12345

Why do researchers think this study treatment might be promising for HIV?

Most treatments for HIV, like antiretroviral therapies, work by preventing the virus from replicating. But VH4527079 might work differently, targeting the virus in a new way. This investigational treatment is administered via IV infusion, which could offer a more controlled delivery compared to traditional oral pills. Researchers are excited because it could potentially provide a new option for managing HIV, possibly with different dosing schedules, which might improve patient adherence and outcomes.

What evidence suggests that VH4527079 might be an effective treatment for HIV?

Research is investigating VH4527079 as a potential treatment for HIV. Although still in the early testing stages, this trial includes different treatment arms to evaluate its effectiveness. Participants in Arm B, Cohort 9, who have HIV, will receive three doses of VH4527079 by IV infusion. Early lab studies have shown that VH4527079 can affect the virus's ability to replicate, potentially reducing the amount of virus in the body. However, as this is a new treatment, more information is needed to determine its effectiveness for people living with HIV.13678

Are You a Good Fit for This Trial?

This trial is for healthy adults and individuals with HIV. Participants must be in good health or have stable HIV suppression if they are living with the virus. The study excludes anyone who has a history of significant allergic reactions, is pregnant or breastfeeding, or has any condition that could interfere with the drug's effects.

Inclusion Criteria

I weigh at least 50 kg if male, 45 kg if female, and my BMI is between 18.5 and 31.
My HIV is well-controlled with first-line INSTI-based therapy, and I've had no history of treatment failure.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
See 5 more

Exclusion Criteria

I have never used HIV Pre-exposure or Post-exposure prophylaxis.
I have a history of heart rhythm problems or heart disease.
I do not have any major health issues that could affect drug processing or pose a risk with the study treatment.
See 26 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple doses of VH4527079 by IV infusion or SC injection

Up to 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VH4527079
Trial Overview The trial tests VH4527079, a human monoclonal antibody, given as a single dose by injection under the skin (SC) or into a vein (IV), and multiple doses by IV to assess its safety and how it's processed in the body.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Group I: Arm B, Cohort 9Experimental Treatment1 Intervention
Group II: Arm B, Cohort 8Experimental Treatment1 Intervention
Group III: Arm A, Cohort 7Experimental Treatment1 Intervention
Group IV: Arm A, Cohort 6Experimental Treatment1 Intervention
Group V: Arm A, Cohort 5Experimental Treatment1 Intervention
Group VI: Arm A, Cohort 4Experimental Treatment1 Intervention
Group VII: Arm A, Cohort 3Experimental Treatment1 Intervention
Group VIII: Arm A, Cohort 2Experimental Treatment1 Intervention
Group IX: Arm A, Cohort 1Experimental Treatment1 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

Citations

NCT06652958 | A Study to Assess the Safety and ...This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by ...
VH4527079 for HIV · Recruiting Participants for Phase ...This Phase 1 medical study run by ViiV Healthcare is evaluating whether VH4527079 will have tolerable side effects & efficacy for patients with AIDS, HIV ...
PipelineAt GSK, our portfolio and pipeline is focused in developing medicines and vaccines in four core therapeutic areas.
Trial | NCT06652958This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by ...
5.treatmentactiongroup.orgtreatmentactiongroup.org/cure/trials/
Research Toward a Cure TrialsA listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials.gov online ...
A Study to Assess the Safety and Pharmacokinetics of a ...This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) ...
A Study to Assess the Safety and Pharmacokinetics ...This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) ...
VH-4527079 - MedPathA Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV. 2024/10/22.
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