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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 12 and 24
Awards & highlights
Study Summary
This trial is testing two different doses of a new medication to see how safe and well-tolerated it is, as well as how it is metabolized by the body.
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.Check my eligibility
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.See study design
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.
Select...
I weigh at least 40 kg and my BMI is between 18 and 32.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 4, 8, 12 and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 12 and 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute value of Hematology parameter: Mean Corpuscle Hemoglobin (MCH) (Picograms)
Absolute value of Hematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Absolute value of Hematology parameter: Platelet count (cells per microliter)
+32 moreSecondary outcome measures
Dose proportionality of Cabotegravir based on AUC(0-inf)
Dose proportionality of Cabotegravir based on AUC(0-t)
Dose proportionality of Cabotegravir based on Cmax
+4 moreSide 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
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/mLExperimental Treatment1 Intervention
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
Cabotegravir 400 mg/mL
2020
Completed Phase 1
~140
Recombinant human hyaluronidase PH20 (rHuPH20)
2020
Completed Phase 2
~270
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
ViiV HealthcareLead Sponsor
361 Previous Clinical Trials
468,587 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,596 Previous Clinical Trials
6,144,281 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 A: Participants receiving CAB 200 mg/mL with rHuPH20
- Group 2: Part C: Participants receiving CAB 400 mg/mL
- Group 3: Part D: Participants receiving CAB 400 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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