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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 cohorts c2, c4, c5, c6, c7, c8, c9 [part c] and for part d)
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 belowSelect...
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:Select...
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 cohorts c2, c4, c5, c6, c7, c8, c9 [part c] and for part d)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of study (week 78 for cohorts c1 and c3 [part c], week 52 for cohorts c2, c4, c5, c6, c7, c8, c9 [part c] and for part d)
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
Side effects data
From 2009 Phase 2 trial • 22 Patients • NCT0077480059%
Blood glucose decreased
23%
Hypoglycaemia
5%
Contusion
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Humalog + rHuPH20
Humulin-R + rHuPH20
Humalog Alone
Humulin-R Alone
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part D: Participants receiving CAB ≥400 mg/mL with rHuPH20Experimental Treatment2 Interventions
Group II: Part C: Participants receiving CAB ≥400 mg/mL or CAB Formulation IExperimental Treatment2 Interventions
Group III: 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
Cabotegravir 200 mg/mL
2020
Completed Phase 1
~140
Recombinant human hyaluronidase PH20 (rHuPH20)
2020
Completed Phase 2
~270
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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ViiV HealthcareLead Sponsor
370 Previous Clinical Trials
469,665 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,602 Previous Clinical Trials
6,144,846 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I have had a heart attack before.My kidney function is reduced, with an eGFR below 60 mL/min.I do not have any heart rhythm problems that could make the trial unsafe for me.I haven't had seizures or needed treatment for them in the last 2 years.I have a history of liver disease or known liver problems.I have not been exposed to more than four new drugs in the last year.I have or had heart, lung, liver, kidney, stomach, hormone, blood, or nerve disorders.I am between 18 and 55 years old.I weigh at least 40 kg and my BMI is between 18 and 32.My blood pressure is not normal.You are negative on two (2) consecutive tests for 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.I need or will need long-term blood thinners.I have a genetic blood clotting disorder like hemophilia or VWD.I have a skin condition or tattoo that could affect the study's injection site.
Research Study Groups:
This trial has the following groups:- Group 1: Part C: Participants receiving CAB ≥400 mg/mL or CAB Formulation I
- Group 2: Part D: Participants receiving CAB ≥400 mg/mL with rHuPH20
- Group 3: Part A: Participants receiving CAB 200 mg/mL with rHuPH20
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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