What side effects are associated with this type of intervention?

Common treatments for HIV infection, particularly Integrase Strand Transfer Inhibitors (INSTIs) like Cabotegravir, are generally well-tolerated but can have side effects. These may include headache, fatigue, and gastrointestinal issues such as nausea and diarrhea. Some patients may experience insomnia or dizziness. Serious side effects are rare but can include hypersensitivity reactions and liver enzyme elevations. When combined with Recombinant Human Hyaluronidase PH20, which enhances drug dispersion and absorption, there may be additional local injection site reactions such as erythema, pain, or bruising.

What prior FDA approvals exist?

The FDA has approved several Integrase Strand Transfer Inhibitors (INSTIs) for the treatment of HIV infection, including Raltegravir, Elvitegravir, Dolutegravir, and Bictegravir. These drugs are often used in combination with other antiretroviral agents to enhance efficacy. For example, Bictegravir is combined with Emtricitabine and Tenofovir Alafenamide in a single-tablet regimen. Cabotegravir, another INSTI, is being studied in combination with Recombinant Human Hyaluronidase PH20 to improve drug dispersion and absorption, potentially offering a long-acting injectable option for HIV treatment. This approach aims to improve adherence and outcomes by reducing the frequency of dosing.

What other types of research exist?

Promising novel alternatives to Cabotegravir with Recombinant Human Hyaluronidase PH20 for HIV treatment in 2024 include: 1) Lenacapavir, a long-acting capsid inhibitor with potential for biannual dosing. 2) Islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI) with long-acting properties. 3) Combination therapies involving long-acting injectable formulations of rilpivirine and cabotegravir, which are already in use and may see further enhancements. These alternatives offer extended dosing intervals and have shown efficacy in clinical trials.

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Antiretroviral Agent

Long-Acting Cabotegravir + rHuPH20 for HIV Infection

Phase 1

Recruiting

Research Sponsored by ViiV Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At the time of obtaining informed consent, participants age should be equal to or greater than (=>)18 years and equal to or less than (=<) 55 years.

Body weight =>40 kilogram (kg) and body mass index (BMI) within the range =>18 to =<32 kilogram per meter square (kg/m^2).

Must not have

Hemoglobin <12.5 gram per deciliter (g/dL) for men and <11 g/dL for women.

Evidence of previous myocardial infarction.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to end of study (week 78 for cohorts c1 and c3 [part c], week 52 for part a, cohorts c2, c4, c5, c6, c7, c8, c9 [part c] and for part d, and week 72 for part e)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a long-lasting HIV medication called Cabotegravir, given as an injection. It also tests if adding rHuPH20 helps the medication spread better in the body. The study focuses on people who need long-term HIV treatment. Cabotegravir is the first long-acting injectable treatment option approved for adults with HIV-1.

Who is the study for?

Healthy adults aged 18-55, with a body weight of at least 40 kg and BMI between 18-32 kg/m^2. Participants must test negative for SARS-CoV-2 twice before dosing, use contraception according to local guidelines, and not have used tobacco or nicotine products within the last three months.

What is being tested?

The trial is testing the safety and how the body processes long-acting Cabotegravir (CAB) given by injection at different strengths (200 mg/mL and 400 mg/mL), with and without an enzyme called rHuPH20. Part A has been closed based on preliminary results.

What are the potential side effects?

Potential side effects may include reactions at the injection site, general discomfort or pain, allergic responses to components in the treatment, changes in liver enzymes which could indicate liver issues, fatigue or flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I weigh at least 40 kg and my BMI is between 18 and 32.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My hemoglobin level is below the normal range for my gender.

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I have had a heart attack before.

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My kidney function is reduced, with an eGFR below 60 mL/min.

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I haven't had seizures or needed treatment for them in the last 2 years.

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I have a history of liver disease or known liver problems.

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I have not been exposed to more than four new drugs in the last year.

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I need or will need long-term blood thinners.

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I have a genetic blood clotting disorder like hemophilia or VWD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to end of study (week 78 for cohorts c1 and c3 [part c], week 52 for part a, cohorts c2, c4, c5, c6, c7, c8, c9 [part c] and for part d, and week 72 for part e)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to end of study (week 78 for cohorts c1 and c3 [part c], week 52 for part a, cohorts c2, c4, c5, c6, c7, c8, c9 [part c] and for part d, and week 72 for part e)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of study (week 78 for cohorts c1 and c3 [part c], week 52 for part a, cohorts c2, c4, c5, c6, c7, c8, c9 [part c] and for part d, and week 72 for part e) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)

Secondary study objectives

Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part E: Participants receiving RPVExperimental Treatment1 Intervention

Group II: Part D: Participants receiving CAB >=400 mg/mL with rHuPH20Experimental Treatment2 Interventions

Group III: Part C: Participants receiving CAB >=400 mg/mL or CAB Formulation IExperimental Treatment2 Interventions

Group IV: Part A: Participants receiving CAB 200 mg/mL with rHuPH20Experimental Treatment2 Interventions

Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rHuPH20

2019

Completed Phase 2

~920

RPV

2014

Completed Phase 2

~530

Cabotegravir 200 mg/mL

2020

Completed Phase 1

~140

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Integrase Strand Transfer Inhibitors (INSTIs) like Cabotegravir inhibit the HIV integrase enzyme, preventing the integration of viral DNA into the host cell genome, which is essential for viral replication. Recombinant Human Hyaluronidase PH20 enhances the dispersion and absorption of the drug, making the treatment more effective. This combination is crucial for HIV patients as it offers a more efficient and potentially long-acting treatment option, improving adherence and reducing the frequency of dosing.