VH4527079 for HIV

Recruiting at 1 trial location

Overseen By US GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ViiV Healthcare

Must be taking: INSTI-based antiretrovirals

Must not be taking: Anticoagulants, Enzyme inducers

Disqualifiers: Cardiovascular disease, Hepatitis, Syphilis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 weeks

86 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose administration by IV infusion in healthy adult participants and in Persons with HIV (PWH).

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.

How does the drug VH4527079 for HIV differ from other treatments?

VH4527079 may involve targeting the CCR5 receptor, which is a key entry point for HIV into cells. This approach is different from many existing treatments that focus on inhibiting viral replication rather than blocking entry. Understanding genetic variations like the CCR5 -2459G > A polymorphism could enhance the effectiveness of such treatments. ^{1 2 3 4 5}

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Arm B, Cohort 9 Experimental Treatment 1 Intervention

Participants with HIV receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval.

Group II: Arm B, Cohort 8 Experimental Treatment 1 Intervention

Healthy adult participants receive three doses of VH4527079 dose that is selected in Arm A, by IV infusion, separated by a time interval.

Group III: Arm A, Cohort 7 Experimental Treatment 1 Intervention

Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by SC injection.

Group IV: Arm A, Cohort 6 Experimental Treatment 1 Intervention

Healthy adult participants receive a single dose of VH4527079 Dose 6 (max dose) by IV infusion.

Group V: Arm A, Cohort 5 Experimental Treatment 1 Intervention

Healthy adult participants receive a single dose of VH4527079 Dose 5 (high dose) by IV infusion.

Group VI: Arm A, Cohort 4 Experimental Treatment 1 Intervention

Healthy adult participants receive a single dose of VH4527079 Dose 4 (mid-high dose) by IV infusion.

Group VII: Arm A, Cohort 3 Experimental Treatment 1 Intervention

Healthy adult participants receive a single dose of VH4527079 Dose 3 (mid-low dose) by IV infusion.

Group VIII: Arm A, Cohort 2 Experimental Treatment 1 Intervention

Healthy adult participants receive a single dose of VH4527079 Dose 2 (low dose) by IV infusion.

Group IX: Arm A, Cohort 1 Experimental Treatment 1 Intervention

Healthy adult participants receive a single dose of VH4527079 Dose 1 (lowest dose) by IV infusion.

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

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

References

1. United States pubmed.ncbi.nlm.nih.gov

CD4-dependent characteristics of coreceptor use and HIV type 1 V3 sequence in a large population of therapy-naive individuals. [2008]

2. Switzerland pubmed.ncbi.nlm.nih.gov

CCR5 Promoter Polymorphism -2459G > A: Forgotten or Ignored? [2020]

3. England pubmed.ncbi.nlm.nih.gov

Correlation between genotypic predictions based on V3 sequences and phenotypic determination of HIV-1 tropism. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

HIV VprR77Q mutation does not influence clinical response of individuals initiating highly active antiretroviral therapy. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Sequence variation and consensus sequence of V3 loop on HIV-1 gp120. [2019]