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.
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1
Study Objectives
61 Primary · 7 Secondary · Reporting Duration: Weeks 4, 8, 12 and 24
Week 52
Change from Baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Change from Baseline in Clinical Chemistry parameters: Glucose (fasting), BUN, Creatinine, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Change from Baseline in Clinical Chemistry parameters: Glucose (fasting), BUN, Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Change from Baseline in Clinical Chemistry parameters: Sodium, Potassium, and Calcium (milliequivalents per liter)
Change from Baseline in Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter)
Change from Baseline in Coagulation parameters: INR
Change from Baseline in Coagulation parameters: PT and PTT
Change from Baseline in Haematology parameter: MCH (picograms per cell)
Change from Baseline in Haematology parameter: MCV (cubic microns)
Change from Baseline in Haematology parameter: Platelet count (cells per microliter)
Change from Baseline in Haematology parameter: RBC Count (million cells per microliter)
Change from Baseline in Haematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (percentage)
Change from Baseline in Haematology parameters: Hematocrit and Reticulocytes (percentage)
Change from Baseline in Haematology parameters: Hgb, albumin and total protein (grams per deciliter)
Change from Baseline in Hematology parameter: MCH (picograms)
Change from Baseline in Hematology parameter: MCV (Femtoliters)
Change from Baseline in Hematology parameter: Platelet count (cells per microliter)
Change from Baseline in Hematology parameter: RBC Count (million cells per microliter)
Change from Baseline in Hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (Giga cells per liter)
Change from Baseline in Hematology parameters: Hematocrit (Proportion of red blood cells in blood)
Change from Baseline in Hematology parameters: Hgb (grams per deciliter)
Change from Baseline in Hematology parameters: Reticulocytes (Percentage of reticulocytes)
Up to Week 52
Absolute value of Coagulation parameter: International normalized ratio (INR)
Absolute value of Haematology parameter: Mean Corpuscle Hemoglobin (MCH) (picograms per cell)
Absolute value of Haematology parameter: Mean Corpuscle Volume (MCV) (cubic microns)
Absolute value of Haematology parameter: Platelet count (cells per microliter)
Absolute value of Haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
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)
Absolute value of Hematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Absolute values of Clinical Chemistry parameters: Sodium, Potassium, and Calcium (milliequivalents per liter)
Absolute values of Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter)
Absolute values of Coagulation parameters: Prothrombin time (PT) and Partial thromboplastin time (PTT)
Absolute values of Haematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (percentage)
Absolute values of Haematology parameters: Haemoglobin (Hgb), albumin and total protein (grams per deciliter)
Absolute values of Haematology parameters: Hematocrit and Reticulocytes (percentage)
Absolute values of Hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Absolute values of Hematology parameters: Hematocrit (Proportion of red blood cells in blood)
Absolute values of Hematology parameters: Hemoglobin (Hgb) (grams per deciliter)
Absolute values of Hematology parameters: Reticulocytes (Percentage of reticulocytes)
Apparent long-acting absorption rate constant (KA-LA) of Cabotegravir
Apparent terminal phase half-life (t1/2) of Cabotegravir
Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of Cabotegravir
Area under the concentration - time curve from time zero to infinity [AUC(0-inf)] of Cabotegravir
Area under the concentration - time curve from time zero to time of last quantifiable concentration or 4 weeks following the injection whichever is earlier (AUC[0-t]) of Cabotegravir
Area under the concentration - time curve from time zero to time of last quantifiable concentration or 4 weeks following the injection whichever is earlier [AUC(0-t)] of Cabotegravir
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
Maximum observed plasma concentration (Cmax) of Cabotegravir
Number of Participants with AEs by Severity
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with Non-serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs)
Number of participants with maximum post-baseline QTc values compared to baseline by category (to <=450 milliseconds (msec) or no change, to >450 msec to <=480 msec, to >480 msec to <=500 msec, and to >500 msec)
Number of participants with maximum post-baseline increase in QTc values compared to baseline based on category (increase <=30 msec, increase of 31-60 msec, and increase of >60 msec)
Number of participants with maximum toxicity grades increase from Baseline in haematology, clinical chemistry and coagulation parameters
Number of participants with maximum toxicity grades increase from Baseline in hematology and clinical chemistry
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
Time of maximum observed plasma concentration (tmax) of Cabotegravir
Week 12
Plasma Concentration of Cabotegravir at Week 12
Week 24
Plasma Concentration of Cabotegravir at Week 24
Week 4
Plasma Concentration of Cabotegravir at Week 4
Week 8
Plasma Concentration of Cabotegravir at Week 8
Week 4
Dose proportionality of Cabotegravir based on plasma concentration
Trial Safety
Phase-Based Safety
Side Effects for
Humalog + rHuPH20
59%Blood glucose decreased
23%Hypoglycaemia
5%Headache
5%Contusion
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
5 Treatment Groups
Part D: Participants receiving CAB 400 mg/mL with rHuPH20
1 of 5
Part A: Participants receiving CAB 200 mg/mL with rHuPH20
1 of 5
Part C: Participants receiving CAB 400 mg/mL
1 of 5
Part B: CAB 400 mg/mL with rHuPH20
1 of 5
Part A: CAB 200 mg/mL with rHuPH20
1 of 5
Experimental Treatment
60 Total Participants · 5 Treatment Groups
Primary Treatment: Recombinant human hyaluronidase PH20 (rHuPH20) · No Placebo Group · Phase 1
Part D: Participants receiving CAB 400 mg/mL with rHuPH20Experimental Group · 2 Interventions: Cabotegravir 400 mg/mL, Recombinant human hyaluronidase PH20 (rHuPH20) · Intervention Types: Drug, Drug
Part A: Participants receiving CAB 200 mg/mL with rHuPH20Experimental Group · 2 Interventions: Cabotegravir 200 mg/mL, Recombinant human hyaluronidase PH20 (rHuPH20) · Intervention Types: Drug, Drug
Part C: Participants receiving CAB 400 mg/mL
Drug
Experimental Group · 1 Intervention: Cabotegravir 400 mg/mL · Intervention Types: DrugPart B: CAB 400 mg/mL with rHuPH20Experimental Group · 2 Interventions: Cabotegravir 400 mg/mL, Recombinant human hyaluronidase PH20 (rHuPH20) · Intervention Types: Drug, Drug
Part A: CAB 200 mg/mL with rHuPH20Experimental Group · 2 Interventions: Cabotegravir 200 mg/mL, Recombinant human hyaluronidase PH20 (rHuPH20) · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabotegravir 400 mg/mL
2020
Completed Phase 1
~140
Cabotegravir 200 mg/mL
2020
Completed Phase 1
~140
Recombinant human hyaluronidase PH20 (rHuPH20)
2020
Completed Phase 2
~270
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 4, 8, 12 and 24
Who is running the clinical trial?
ViiV HealthcareLead Sponsor
338 Previous Clinical Trials
462,357 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,573 Previous Clinical Trials
6,137,030 Total Patients Enrolled
Eligibility Criteria
Age 18 - 55 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Nevada | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| GSK Investigational Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- GSK Investigational Site: < 48 hours
Typically responds via
| 100.0% | |
Frequently Asked Questions
Are there any dangers associated with Recombinant human hyaluronidase PH20 (rHuPH20)?
"Because this is a Phase 1 trial, there is only limited data supporting the safety and efficacy of Recombinant human hyaluronidase PH20 (rHuPH20), so our team at Power gave it a score of 1." - Anonymous Online Contributor
Unverified Answer
Who would be the best candidate for this research?
"This clinical trial is for 60 participants who are HIV positive and between the ages of 18 and 55. The following additional criteria must be met: participants must be healthy as determined by medical evaluation, have a body weight of at least 40 kg and a BMI within the range of 18-32 kg/m^2, be using contraception consistently, be able to give written informed consent, and have two negative tests for SARS-CoV-2 prior to admission to the Phase 1 unit and prior to dosing." - Anonymous Online Contributor
Unverified Answer
Are participants in this clinical trial restricted to a certain age range?
"This study's parameters for inclusion state that only patients aged 18 to 55 may enroll. However, there are 109 other clinical trials available for minors and 364 for elderly patients." - Anonymous Online Contributor
Unverified Answer