Long-Acting Cabotegravir + rHuPH20 for HIV Infection
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: ViiV Healthcare
Must not be taking: Anticoagulants, Drugs of abuse
Disqualifiers: Cardiovascular, Liver disease, HIV, others
No Placebo Group
Breakthrough Therapy
Approved in 5 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12678What 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.
12345Eligibility Criteria
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 am between 18 and 55 years old.
I weigh at least 40 kg and my BMI is between 18 and 32.
+4 more
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.
+25 more
Trial Timeline
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
Participant Groups
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.
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.
Cabotegravir is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Vocabria for:
- HIV-1 infection
🇺🇸 Approved in United States as Vocabria for:
- HIV-1 infection
🇨🇦 Approved in Canada as Vocabria for:
- HIV-1 infection
🇯🇵 Approved in Japan as Vocabria for:
- HIV-1 infection
🇦🇺 Approved in Australia as Vocabria for:
- HIV-1 infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
GSK Investigational SiteBerlin, NJ
GSK Investigational SiteOrlando, FL
GSK Investigational SiteAustin, TX
GSK Investigational SiteLas Vegas, NV
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Who Is Running the Clinical Trial?
ViiV HealthcareLead Sponsor
GlaxoSmithKlineIndustry Sponsor
Janssen Sciences Ireland Unlimited CompanyCollaborator
References
A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV. [2023]Cabotegravir (CAB) and rilpivirine (RPV) is the first long-acting injectable antiretroviral therapy (ART) option approved for virologically suppressed adults with HIV-1. In addition, long-acting CAB is a promising agent for HIV preexposure prophylaxis (PrEP). This review focuses on phase 3 clinical trial results and implementation considerations for these long-acting ART and PrEP strategies.
Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. [2023]Cabotegravir (CAB) is a novel strand-transfer integrase inhibitor being developed for HIV treatment and prevention. CAB is formulated both as an immediate-release oral tablet for daily administration and as a long-acting injectable suspension (long-acting CAB [CAB LA]) for intramuscular (IM) administration, which delivers prolonged plasma exposure to the drug after IM injection. HIV Prevention Trials Network study 077 (HPTN 077) evaluated the safety, tolerability, and pharmacokinetics of CAB LA in HIV-uninfected males and females at 8 sites in Brazil, Malawi, South Africa, and the United States.
Immune Reconstitution Inflammatory Syndrome in Aids Patient After Successful Induction of Virological Suppression with Cabotegravir/Rilpivirine. [2023]Long-acting (LA) cabotegravir/rilpivirine (CAB/RPV) is a complete regimen for the management of human immunodeficiency virus type 1 (HIV-1) infection to replace their oral antiretroviral therapy (ART) when they have been virologically suppressed. We present a case of successful achievement of undetectable HIV RNA viral load levels in an acquired immunodeficiency syndrome (AIDS) patient with long-standing virologic failure within two months of CAB/RPV LA initiation. This was later complicated by immune reconstitution inflammatory syndrome (IRIS) due to Mycobacterium avium-intracellulare (MAI) infection and hepatitis B virus (HBV) reactivation.
Cabotegravir + Rilpivirine Long-Acting Injections for HIV Treatment in the US: Real World Data from the OPERA Cohort. [2023]The first complete long-acting antiretroviral therapy (ART) regimen, cabotegravir + rilpivirine long-acting (CAB + RPV LA) injectable, was approved in the US for HIV-1 treatment in individuals on a stable antiretroviral regimen with a viral load
A literature review of the patent application publications on cabotegravir - an HIV integrase strand transfer inhibitor. [2020]Introduction: Studies presented in the patent applications demonstrate that a new integrase strand transfer inhibitor cabotegravir might be used as long-acting antiretroviral formulation or delivery system that reduces dosing frequency and may therefore increase adherence and thus pre-exposure prophylaxis (PrEP) and treatment efficacy against HIV. As announced in 2019, the developer ViiV Healthcare seeks US and EU approval of long-acting, injectable HIV treatment.Area covered: This review covers all the patent applications published until October 2019 with cabotegravir in the examples or claim section of the patent application document. The patent applications cover drug substance synthesis, solid-state forms, therapeutic applications, in vitro and in vivo efficacy as well as the potential formulations of cabotegravir alone or in combination with other anti-HIV agents.Expert opinion: The results from multiple clinical studies suggest that cabotegravir can be used as PrEP agent and treatment agent against HIV. Multiple studies use cabotegravir in combination with other anti-HIV agents such as rilpivirine. Cabotegravir in combination with rilpivirine is an interesting therapeutic, due to the possibility of formulating long-acting formulation with dosing interval of every 4 weeks or less, thus reducing daily pill burden and improving patient's compliance.
Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection. [2022]To review the efficacy and safety of cabotegravir (CAB) with rilpivirine (RPV) in the treatment of HIV-1 infection.
Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. [2023]Long-acting formulations of cabotegravir (CAB) and rilpivirine (RPV) have demonstrated efficacy in Phase 3 studies. POLAR (NCT03639311) assessed antiviral activity and safety of CAB+RPV long-acting administered every 2 months (Q2M) in adults living with HIV-1 who previously received daily oral CAB+RPV in LATTE (NCT01641809).
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]WHO guidelines recommend daily oral tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) for pre-exposure prophylaxis (PrEP) of HIV in people at high risk of HIV infection. However, due to social, psychological and other reasons, the compliance with daily oral TDF-FTC in real life is low. Long-acting cabotegravir is currently the only long-acting drug approved by the U.S. Food and Drug Administration (FDA) for HIV PrEP. Due to the long dosing interval (8 weeks), long-acting cabotegravir has low compliance requirements for people at high risk of HIV infection. We aimed to discuss the feasibility of long-acting cabotegravir to replace TDF-FTC as HIV PrEP based on efficacy and safety analyses. Randomized controlled trials were retrieved, and R software was used for meta-analysis after data extraction. and discussion: Results of the meta-analysis showed that compared with TDF-FTC, long-acting cabotegravir was associated with a lower risk of HIV infection (HR = 0.22, 95% CI: 0.08-0.59, p 0.05). Long-acting cabotegravir has a manageable safety profile and is more effective than TDF-FTC in preventing HIV infection. Interestingly, decreased creatinine clearance occurred less frequently with long-acting cabotegravir than with TDF-FTC. Long-acting cabotegravir is very promising to replace TDF-TFC in the future, which requires more large-sample, high-quality RCTs to verify.