180 Participants Needed

Long-Acting Cabotegravir + rHuPH20 for HIV Infection

Recruiting at 2 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is long-acting cabotegravir safe for humans?

Long-acting cabotegravir has been shown to have a manageable safety profile in clinical trials, both for treating HIV and as a preventive measure. It is generally well-tolerated, with fewer issues related to kidney function compared to some other HIV medications.12345

What makes the drug Cabotegravir unique for HIV treatment?

Cabotegravir is unique because it is a long-acting injectable drug that can be administered every 4 weeks or less, reducing the need for daily pills and potentially improving adherence to treatment. It is used in combination with rilpivirine and is the first long-acting injectable option approved for people with HIV-1 who are already virologically suppressed.23678

What data supports the effectiveness of the drug Long-Acting Cabotegravir + rHuPH20 for HIV infection?

Long-acting cabotegravir, when used with rilpivirine, has been shown to effectively manage HIV by maintaining undetectable viral loads in patients who were already virologically suppressed. It is also promising for HIV prevention, as it provides prolonged drug exposure, which can improve adherence and treatment success.23678

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

ViiV Healthcare

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants who are negative on two (2) consecutive tests for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), one performed prior to admission to the Phase 1 unit (up to Day 7 prior to admission) and one prior to dosing, i.e., on Day -1 or Day 1.
I weigh at least 40 kg and my BMI is between 18 and 32.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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Exclusion Criteria

Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
I have had COVID-19 symptoms or contact with a COVID-19 positive person in the last 14 days.
My hemoglobin level is below the normal range for my gender.
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single subcutaneous or intramuscular administration of long-acting Cabotegravir with or without Recombinant Human Hyaluronidase PH20, and single-dose or repeat-dose IM administration of rilpivirine

Up to 78 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cabotegravir
  • Recombinant human hyaluronidase PH20 (rHuPH20)
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Part E: Participants receiving RPVExperimental Treatment1 Intervention
Group II: Part C: Participants receiving CAB >=400 mg/mL or CAB Formulation I or CAB Formulation JExperimental Treatment3 Interventions
Group III: Part A: Participants receiving CAB 200 mg/mL with rHuPH20Experimental Treatment2 Interventions

Cabotegravir is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Vocabria for:
🇺🇸
Approved in United States as Vocabria for:
🇨🇦
Approved in Canada as Vocabria for:
🇯🇵
Approved in Japan as Vocabria for:

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

GlaxoSmithKline

Industry Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Janssen Sciences Ireland Unlimited Company

Collaborator

Trials
1
Recruited
180+

Published Research Related to This Trial

Long-acting injectable therapies, cabotegravir (CAB) and rilpivirine (RPV), have been shown to be as effective as traditional oral antiretroviral therapy (ART) for HIV-1, maintaining efficacy over 96 weeks in clinical trials with virologically suppressed adults.
CAB has also demonstrated effectiveness as a preexposure prophylaxis (PrEP) option, significantly reducing HIV infections compared to daily oral medication, indicating its potential for broader use in HIV prevention.
A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV.Bares, SH., Scarsi, KK.[2023]
Cabotegravir long-acting injectable (CAB LA) was found to be well tolerated among participants, with a high completion rate of injections (80% in Cohort 1 and 92% in Cohort 2), despite common injection site reactions (ISRs) that were mostly mild to moderate.
The study demonstrated that CAB LA 600 mg administered every 8 weeks successfully maintained drug levels above effective thresholds in 95% of participants, supporting its potential for HIV prevention and treatment.
Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial.Landovitz, RJ., Li, S., Grinsztejn, B., et al.[2023]
Long-acting cabotegravir/rilpivirine (CAB/RPV) was effective in achieving undetectable HIV RNA levels in a patient with a history of virologic failure within just two months of treatment initiation.
The case also highlights the occurrence of immune reconstitution inflammatory syndrome (IRIS) due to Mycobacterium avium-intracellulare infection after starting CAB/RPV, indicating that while the treatment is effective, it can lead to complications in patients with underlying infections.
Immune Reconstitution Inflammatory Syndrome in Aids Patient After Successful Induction of Virological Suppression with Cabotegravir/Rilpivirine.Al-Handola, R., Chinnappan, J., Bakeer, M., et al.[2023]

Citations

A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV. [2023]
Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. [2023]
Immune Reconstitution Inflammatory Syndrome in Aids Patient After Successful Induction of Virological Suppression with Cabotegravir/Rilpivirine. [2023]
Cabotegravir + Rilpivirine Long-Acting Injections for HIV Treatment in the US: Real World Data from the OPERA Cohort. [2023]
A literature review of the patent application publications on cabotegravir - an HIV integrase strand transfer inhibitor. [2020]
Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection. [2022]
Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. [2023]
Efficacy and safety of long-acting cabotegravir versus oral tenofovir disoproxil fumarate-emtricitabine as HIV pre-exposure prophylaxis: A systematic review and meta-analysis. [2023]
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