Trial Outcomes & Findings for A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men (NCT NCT03422172)
NCT ID: NCT03422172
Last Updated: 2021-05-13
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or other situations as per investigator's judgement.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Week 5 to 41
Results posted on
2021-05-13
Participant Flow
This was an open-label, multi-site study to evaluate pharmacokinetic (PK), safety, tolerability, and acceptability of long acting (LA) injections of cabotegravir (CAB) in human immunodeficieny virus (HIV) uninfected Chinese men.
A total of 48 participants were enrolled and randomized to receive study treatment. The study consisted of oral lead-in phase (4 weeks), injection phase (weeks 5 to 41) and long-term follow-up phase (weeks 42 to 89).
Participant milestones
| Measure |
Cabotegravir
Participants received 30 milligrams (mg) Cabotegravir tablet once daily orally for 4 weeks. Participants who completed the oral lead-in phase, received CAB LA 600 mg administered as a single 3 milliliter (mL) intramuscular (IM) injection on Weeks 5, 9, 17, 25 and 33 during injection phase. There was a washout of 7 days between oral and Injection phase. Participants were followed-up till Week 89 (long-term follow-up phase).
|
|---|---|
|
Oral lead-in Phase (4 Weeks)
STARTED
|
48
|
|
Oral lead-in Phase (4 Weeks)
COMPLETED
|
47
|
|
Oral lead-in Phase (4 Weeks)
NOT COMPLETED
|
1
|
|
Washout (7 Days)
STARTED
|
47
|
|
Washout (7 Days)
COMPLETED
|
47
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
|
Injection Phase (Week 5 to Week 41)
STARTED
|
47
|
|
Injection Phase (Week 5 to Week 41)
COMPLETED
|
43
|
|
Injection Phase (Week 5 to Week 41)
NOT COMPLETED
|
4
|
|
Long Term Follow-up Phase(Upto Week 89)
STARTED
|
43
|
|
Long Term Follow-up Phase(Upto Week 89)
COMPLETED
|
43
|
|
Long Term Follow-up Phase(Upto Week 89)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Cabotegravir
Participants received 30 milligrams (mg) Cabotegravir tablet once daily orally for 4 weeks. Participants who completed the oral lead-in phase, received CAB LA 600 mg administered as a single 3 milliliter (mL) intramuscular (IM) injection on Weeks 5, 9, 17, 25 and 33 during injection phase. There was a washout of 7 days between oral and Injection phase. Participants were followed-up till Week 89 (long-term follow-up phase).
|
|---|---|
|
Oral lead-in Phase (4 Weeks)
Adverse Event
|
1
|
|
Injection Phase (Week 5 to Week 41)
Lost to Follow-up
|
1
|
|
Injection Phase (Week 5 to Week 41)
Withdrawal by Subject
|
3
|
Baseline Characteristics
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
Baseline characteristics by cohort
| Measure |
Cabotegravir
n=48 Participants
Participants received 30 milligrams (mg) Cabotegravir tablet once daily orally for 4 weeks. Participants who completed the oral lead-in phase, received CAB LA 600 mg administered as a single 3 milliliter (mL) intramuscular (IM) injection on Weeks 5, 9, 17, 25 and 33 during injection phase. There was a washout of 7 days between oral and Injection phase. Participants were followed-up till Week 89 (long-term follow-up phase).
|
|---|---|
|
Age, Continuous
|
31.1 Years
STANDARD_DEVIATION 8.11 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
48 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population. It comprised of all participants who received at least one CAB LA injection.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or other situations as per investigator's judgement.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=47 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs): Injection Phase
Non-serious AEs
|
47 Participants
|
|
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs): Injection Phase
SAEs
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category title).
Hematology parameters were graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: Activated partial thromboplastin time (APTT) prolonged, hemoglobin (Hb) (increased), white blood cells (WBC) (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=47 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Platelets (decreased), Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
APTT prolonged, Grade 0, n=28
|
28 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
APTT prolonged, Grade 1, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
APTT prolonged, Grade 2, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
APTT prolonged, Grade 3, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
APTT prolonged, Grade 4, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Hb (increased), Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Hb (increased), Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Hb (increased), Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Hb (increased), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Hb (increased), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
WBC (decreased), Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
WBC (decreased), Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
WBC (decreased), Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
WBC (decreased), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
WBC (decreased), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Lymphocytes count (decreased), Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Lymphocytes count (decreased), Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Lymphocytes count (decreased), Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Lymphocytes count (decreased), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Lymphocytes count (decreased), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Neutrophils (decreased), Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Neutrophils (decreased), Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Neutrophils (decreased), Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Neutrophils (decreased), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Neutrophils (decreased), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Platelets (decreased), Grade 0, n=47
|
45 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Platelets (decreased), Grade 1, n=47
|
2 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Platelets (decreased), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Platelets (decreased), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Prothrombin INR (increased), Grade 0, n=28
|
28 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Prothrombin INR (increased), Grade 1, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Prothrombin INR (increased), Grade 2, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Prothrombin INR (increased),Grade 3, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Prothrombin INR (increased), Grade 4, n=28
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category title).
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), bilirubin, calcium (hypercalcemia and hypocalcemia), carbon dioxide (CO2) (decreased), cholesterol (high), Creatine phosphokinase (CPK) increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=47 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALT, Grade 0, n=47
|
41 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALT, Grade 1, n=47
|
6 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALT, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALT, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALT, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Albumin, Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Albumin, Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Albumin, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Albumin, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Albumin, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALP, Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALP, Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALP, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALP, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
ALP, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
AST, Grade 0, n=47
|
39 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
AST, Grade 1, n=47
|
6 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
AST, Grade 2, n=47
|
2 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
AST, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
AST, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Bilirubin, Grade 0, n=47
|
45 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Bilirubin, Grade 1, n=47
|
2 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Bilirubin, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Bilirubin, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Bilirubin, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypercalcemia, Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypercalcemia, Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypercalcemia, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypercalcemia, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypercalcemia, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypocalcemia, Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypocalcemia, Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypocalcemia, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypocalcemia, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Calcium, Hypocalcemia, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CO2 decreased, Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CO2 decreased, Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CO2 decreased, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CO2 decreased Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CO2 decreased, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Cholesterol (High), Grade 0, n=28
|
26 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Cholesterol (High), Grade 1, n=28
|
2 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Cholesterol (High), Grade 2, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Cholesterol (High), Grade 3, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Cholesterol (High), Grade 4, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CPK increased, Grade 0, n=47
|
38 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CPK increased, Grade 1, n=47
|
4 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CPK increased, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CPK increased, Grade 3, n=47
|
4 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
CPK increased, Grade 4, n=47
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine increased, Grade 0, n=47
|
46 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine increased, Grade 1, n=47
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine increased, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine increased, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine increased, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine clearance decreased, Grade 0, n=47
|
31 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine clearance decreased, Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine clearance decreased, Grade 2, n=47
|
16 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine clearance decreased, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Creatinine clearance decreased, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hyperglycemia), Grade 0, n=47
|
38 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hyperglycemia), Grade 1, n=47
|
7 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hyperglycemia), Grade 2, n=47
|
2 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hyperglycemia), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hyperglycemia), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hypoglycemia), Grade 0, n=47
|
46 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hypoglycemia), Grade 1, n=47
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hypoglycemia), Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hypoglycemia), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Glucose (hypoglycemia), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypophosphatemia, Grade 0, n=47
|
45 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypophosphatemia, Grade 1, n=47
|
2 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypophosphatemia, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypophosphatemia, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypophosphatemia, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hyperkalemia), Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hyperkalemia), Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hyperkalemia), Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hyperkalemia), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hyperkalemia), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hypokalemia), Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hypokalemia), Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hypokalemia), Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hypokalemia), Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Potassium (Hypokalemia), Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hypernatremia, Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hypernatremia, Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hypernatremia, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hypernatremia, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hypernatremia, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hyponatremia, Grade 0, n=47
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hyponatremia, Grade 1, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hyponatremia, Grade 2, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hyponatremia, Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Sodium, hyponatremia, Grade 4, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypertriglyceridemia, Grade 0, n=28
|
21 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypertriglyceridemia, Grade 1, n=28
|
6 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypertriglyceridemia, Grade 2, n=28
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypertriglyceridemia, Grade 3, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Hypertriglyceridemia, Grade 4, n=28
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Uric acid increased, Grade 0, n=47
|
32 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Uric acid increased, Grade 1, n=47
|
14 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Uric acid increased, Grade 2, n=47
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Uric acid increased ,Grade 3, n=47
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Uric acid increased, Grade 4, n=47
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population. Only those participants with data available at the specified time points were analyzed.
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=29 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase
Protein, Grade 0
|
29 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase
Protein, Grade 1
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase
Protein, Grade 2
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase
Protein, Grade 3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase
Protein, Grade 4
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population.
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: systolic blood pressure (SBP) (Low: \<85 millimeters of mercury \[mmHg\], High: \>160 mmHg), diastolic blood pressure (DBP) (Low: \<45 mmHg, High: \>100 mmHg), pulse rate (Low: \<40 mmHg, High: \>100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=47 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
SBP, To low
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
SBP, To Normal or No Change
|
46 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
SBP, To High
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
DBP, To low
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
DBP, To Normal or No Change
|
46 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
DBP, To High
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
Pulse rate, To low
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
Pulse rate, To Normal or No Change
|
46 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
Pulse rate, To High
|
1 Participants
|
PRIMARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=47 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants Withdrawn Due to AEs- Injection Phase
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population
Injection site reactions were recorded via ISR diaries and managed through investigator assessment. Number of participants who experienced any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) is presented.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=47 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants Experiencing Injection Site Reactions (ISR)-Injection Phase
|
47 Participants
|
PRIMARY outcome
Timeframe: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dosePopulation: Oral Pharmacokinetic (PK) Population. It consisted of all participants in the 'Safety Population' for whom an intensive oral PK sample was obtained and analyzed. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Ctau following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=17 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Concentration of Cabotegravir in Plasma at the End of the Dosing Interval (Ctau)-Oral lead-in Phase
|
6.807 Micrograms per milliliter
Geometric Coefficient of Variation 26.8
|
PRIMARY outcome
Timeframe: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dosePopulation: Oral PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=17 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Dosing of Cabotegravir-Oral lead-in Phase
|
191.1 Hour*micrograms per milliliter
Geometric Coefficient of Variation 20.5
|
PRIMARY outcome
Timeframe: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dosePopulation: Oral PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Cmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=17 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Maximum Observed Concentration (Cmax) Following Oral Dosing With Cabogegravir-Oral lead-in Phase
|
10.447 Micrograms per milliliter
Geometric Coefficient of Variation 19.5
|
PRIMARY outcome
Timeframe: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dosePopulation: Oral PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Tmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=17 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Time of Occurrence of Cmax (Tmax) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
|
2.0000 Hours
Interval 0.983 to 4.0
|
PRIMARY outcome
Timeframe: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dosePopulation: Oral PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of CL/F following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=17 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Apparent Clearance Following Oral Dosing (CL/F) Following Dosing With Cabotegravir-Oral lead-in Phase
|
0.1570 Liters per hour
Geometric Coefficient of Variation 20.5
|
PRIMARY outcome
Timeframe: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dosePopulation: Oral PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of t1/2 following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=17 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Terminal Absorption Elimination Half-life (t1/2) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
|
45.24 Hours
Geometric Coefficient of Variation 20.5
|
PRIMARY outcome
Timeframe: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dosePopulation: Oral PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Lambda z following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=17 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Apparent Terminal Phase Rate Constant (Lambda z) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
|
0.01532 Per hour
Geometric Coefficient of Variation 20.5
|
PRIMARY outcome
Timeframe: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dosePopulation: Oral PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Vss following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=17 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Volume of Distribution at Steady State (Vss) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
|
10.246 Liters
Geometric Coefficient of Variation 17.8
|
PRIMARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41Population: Injection (Week 41) PK Population. It consisted of all participants in the 'Safety Population' for whom an injection PK sample was obtained and analyzed during Weeks 5 to 41. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=43 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Ctau Following IM Dosing With CAB LA During Injection Phase
|
1.5831 Micrograms per milliliter
Geometric Coefficient of Variation 43.1
|
PRIMARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41Population: Injection (Week 41) PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of AUC (0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=43 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
AUC(0-tau) Following IM Dosing With CAB LA During Injection Phase
|
3415.1 Hour*micrograms per milliliter
Geometric Coefficient of Variation 41.9
|
PRIMARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41Population: Injection (Week 41) PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=44 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Cmax Following IM Dosing With CAB LA During Injection Phase
|
3.730 Micrograms per milliliter
Geometric Coefficient of Variation 66.1
|
PRIMARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41Population: Injection (Week 41) PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=44 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Tmax Following IM Dosing With CAB LA During Injection Phase
|
167.433 Hour
Interval 0.0 to 765.25
|
SECONDARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89Population: Injection (Week 89) PK Population. It consisted of all participants in the 'Safety Population' for whom an injection PK sample was obtained and analyzed during Weeks 5 to 89 (through Injection and long-term follow-up phases). Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=43 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Ctau Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
|
1.5831 Micrograms per milliliter
Geometric Coefficient of Variation 43.1
|
SECONDARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89Population: Injection (Week 89) PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=43 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
AUC(0-tau) Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
|
3442.5 Hour*micrograms per milliliter
Geometric Coefficient of Variation 41.1
|
SECONDARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89Population: Injection (Week 89) (PK) Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=44 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Cmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
|
3.730 Micrograms per milliliter
Geometric Coefficient of Variation 66.1
|
SECONDARY outcome
Timeframe: Pre-dose sample on Weeks 7 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89Population: Injection (Week 89) PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=44 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Tmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
|
167.433 Hour
Interval 0.0 to 765.25
|
SECONDARY outcome
Timeframe: Pre-dose sample on Weeks 7, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89Population: Injection (Week 89) PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of CL/F following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=43 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
CL/F Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
|
0.17429 Liters per hour
Geometric Coefficient of Variation 41.1
|
SECONDARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89Population: Injection (Week 89) PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of t1/2 following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=41 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
T1/2 Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
|
1128.6 Hour
Geometric Coefficient of Variation 71.2
|
SECONDARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89Population: Injection (Week 89) (PK) Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Lambda z following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=41 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Lambda z Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
|
0.0006141 Per hour
Geometric Coefficient of Variation 71.2
|
SECONDARY outcome
Timeframe: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89Population: Injection (Week 89) (PK) Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at the indicated time points for the determination of Vss following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=41 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Vss Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
|
282.44 Liters
Geometric Coefficient of Variation 124.8
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Safety Population. It comprised all participants who received at least 1 dose of the study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity, Is a congenital anomaly/birth defect, other situation as per investigator's judgement.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=48 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Non-serious AEs and SAEs (Oral lead-in Phase)
Non-serious AEs
|
13 Participants
|
|
Number of Participants With Non-serious AEs and SAEs (Oral lead-in Phase)
SAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=48 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants Withdrawn Due to AEs-oral lead-in Phase
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category title).
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included ALT, albumin, ALP, AST, bilirubin, calcium (hypercalcemia and hypocalcemia), CO2 decreased, cholesterol, CPK increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=48 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALT, Grade 0, n=48
|
45 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALT, Grade 1, n=48
|
3 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALT, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALT, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALT, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Albumin, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Albumin, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Albumin, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Albumin, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Albumin, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALP, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALP, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALP, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALP, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
ALP, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
AST, Grade 0, n=48
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
AST, Grade 1, n=48
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
AST, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
AST, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
AST, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Bilirubin, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Bilirubin, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Bilirubin, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Bilirubin, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Bilirubin, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypercalcemia, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypercalcemia, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypercalcemia, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypercalcemia, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypercalcemia, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypocalcemia, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypocalcemia, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypocalcemia, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypocalcemia, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Calcium, Hypocalcemia, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CO2 decreased, Grade 0, n=48
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CO2 decreased, Grade 1, n=48
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CO2 decreased, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CO2 decreased, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CO2 decreased, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Cholesterol (High), Grade 0, n=3
|
3 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Cholesterol (High), Grade 1, n=3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Cholesterol (High), Grade 2, n=3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Cholesterol (High), Grade 3, n=3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Cholesterol (High), Grade 4, n=3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CPK increased, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CPK increased, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CPK increased, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CPK increased, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
CPK increased, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine increased, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine increased, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine increased, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine increased, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine increased, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine clearance decreased, Grade 0, n=48
|
39 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine clearance decreased, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine clearance decreased, Grade 2, n=48
|
9 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine clearance decreased, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Creatinine clearance decreased, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hyperglycemia), Grade 0, n=48
|
41 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hyperglycemia), Grade 1, n=48
|
7 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hyperglycemia), Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hyperglycemia), Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hyperglycemia), Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hypoglycemia), Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hypoglycemia), Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hypoglycemia), Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hypoglycemia), Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Glucose (hypoglycemia), Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypophosphatemia, Grade 0, n=48
|
46 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypophosphatemia, Grade 1, n=48
|
2 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypophosphatemia, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypophosphatemia, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypophosphatemia, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hyperkalemia), Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hyperkalemia), Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hyperkalemia), Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hyperkalemia), Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hyperkalemia), Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hypokalemia), Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hypokalemia), Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hypokalemia), Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hypokalemia), Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Potassium (Hypokalemia), Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hypernatremia, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hypernatremia, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hypernatremia, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hypernatremia, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hypernatremia, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hyponatremia, Grade 0, n=48
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hyponatremia, Grade 1, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hyponatremia, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hyponatremia, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Sodium, hyponatremia, Grade 4, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypertriglyceridemia, Grade 0, n=3
|
2 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypertriglyceridemia, Grade 1, n=3
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypertriglyceridemia, Grade 2, n=3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypertriglyceridemia, Grade 3, n=3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Hypertriglyceridemia, Grade 4, n=3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Uric acid increased, Grade 0, n=48
|
42 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Uric acid increased, Grade 1, n=48
|
6 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Uric acid increased, Grade 2, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Uric acid increased, Grade 3, n=48
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Uric acid increased, Grade 4, n=48
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Safety Population.
Hematology parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: APTT prolonged, Hb (increased), WBC (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=48 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
APTT prolonged, Grade 0
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
APTT prolonged, Grade 1
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
APTT prolonged, Grade2
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
APTT prolonged, Grade 3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
APTT prolonged, Grade 4
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Hb (increased), Grade 0
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Hb (increased), Grade 1
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Hb (increased), Grade 2
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Hb (increased), Grade 3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Hb (increased), Grade 4
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
WBC (decreased), Grade 0
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
WBC (decreased), Grade 1
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
WBC (decreased), Grade 2
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
WBC (decreased), Grade 3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
WBC (decreased), Grade 4
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Lymphocytes count (decreased), Grade 0
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Lymphocytes count (decreased), Grade 1
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Lymphocytes count (decreased), Grade 2
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Lymphocytes count (decreased), Grade 3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Lymphocytes count (decreased), Grade 4
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Neutrophils (decreased), Grade 0
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Neutrophils (decreased), Grade 1
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Neutrophils (decreased), Grade 2
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Neutrophils (decreased), Grade 3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Neutrophils (decreased), Grade 4
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Platelets (decreased), Grade 0
|
47 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Platelets (decreased), Grade 1
|
1 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Platelets (decreased), Grade 2
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Platelets (decreased), Grade 3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Platelets (decreased), Grade 4
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Prothrombin INR (increased), Grade 0
|
48 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Prothrombin INR (increased), Grade 1
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Prothrombin INR (increased), Grade 2
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Prothrombin INR (increased), Grade 3
|
0 Participants
|
|
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Prothrombin INR (increased), Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Safety Population.
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=48 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Abnormal Urinalysis Parameters: Oral lead-in Phase
Protein, Grade 1
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters: Oral lead-in Phase
Protein, Grade 2
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters: Oral lead-in Phase
Protein, Grade 3
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters: Oral lead-in Phase
Protein, Grade 4
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters: Oral lead-in Phase
Protein, Grade 0
|
48 Participants
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Safety Population.
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: SBP (Low \<85 mmHg, High: \>160 mmHg), DBP (Low: \<45 mmHg, High: \>100 mmHg), pulse rate (Low: \<40 mmHg, High: \>100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=48 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
SBP, To low
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
SBP, To Normal or No Change
|
48 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
SBP, To High
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
DBP, To low
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
DBP, To Normal or No Change
|
48 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
DBP, To High
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
Pulse rate, To low
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
Pulse rate, To Normal or No Change
|
48 Participants
|
|
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
Pulse rate, To High
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population
Percentage of participants with injection discontinuation is presented.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=47 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Percentage of Participants With Injection Discontinuation-Injection Phase
|
4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 5 to 41Population: Safety Injection Population.
Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity is categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated. Higher grade indicates more severe condition. Number of participants who had at least one Grade 2 to 4 Injection site reaction is presented.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=47 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Grade 2 to 4 Injection Site Pain-Injection Phase
|
18 Participants
|
SECONDARY outcome
Timeframe: At Week 10Population: Safety Injection Population. Only those participants with data available at the specified time points were analyzed.
HIV-Prevention Treatment Satisfaction Questionnaire (change) (HIV-PrevTSQc) was used to assess participant tolerability and satisfaction to the treatment. It consisted total 13 questions. The experience of HIV prevention treatment was assessed using a scale from 3 (much more satisfied/effective/convenient/ flexible/likely to recommend the treatment/likely to speak well of the treatment/easier now) to -3 (much less satisfied/effective/convenient/flexible/likely to recommend the treatment/likely to speak well of the treatment/easier now). Total score was calculated by taking sum of scores of all questions. It ranges from -39 to 39, with higher scores indicating more satisfaction.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=45 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
HIV-Prevention Treatment Satisfaction Total Score-Injection Phase
|
23.7 Scores on scale
Standard Deviation 8.55
|
SECONDARY outcome
Timeframe: Up to Week 41Population: Safety Population.
Number of participants who consider using cabotegravir for HIV prevention in the future is presented. Participants were asked if they would consider using cabotegravir for HIV prevention in the future and their answers to this question were recorded as 'Yes', 'No' or 'Missing'.
Outcome measures
| Measure |
CAB LA 600 mg (Injection Phase)
n=48 Participants
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
|---|---|
|
Number of Participants With Acceptability of Cabotegravir for HIV Prevention
Yes
|
40 Participants
|
|
Number of Participants With Acceptability of Cabotegravir for HIV Prevention
No
|
7 Participants
|
|
Number of Participants With Acceptability of Cabotegravir for HIV Prevention
Missing
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Week 41Population: Safety Population. This was a conditional secondary endpoint for which results are not available because population pharmacokinetic (Pop PK) analyses were not conducted.
Relationship between safety and tolerability parameters with cabotegravir PK parameters was planned to be analyzed.
Outcome measures
Outcome data not reported
Adverse Events
CAB 30 mg - Oral lead-in Phase
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
CAB LA 600 mg - Injection Phase
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
CAB LA 600 mg - Long-term Follow-up Phase
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAB 30 mg - Oral lead-in Phase
n=48 participants at risk
Participants received 30 mg Cabotegravir tablet once daily orally for 4 weeks during oral lead-in phase.
|
CAB LA 600 mg - Injection Phase
n=47 participants at risk
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
CAB LA 600 mg - Long-term Follow-up Phase
n=47 participants at risk
After Injection phase, participants were followed-up till Week 89 (long-term follow-up phase).
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
2.1%
1/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
Other adverse events
| Measure |
CAB 30 mg - Oral lead-in Phase
n=48 participants at risk
Participants received 30 mg Cabotegravir tablet once daily orally for 4 weeks during oral lead-in phase.
|
CAB LA 600 mg - Injection Phase
n=47 participants at risk
Participants received CAB LA 600 mg administered as a single 3 mL intramuscular injection on Weeks 5, 9, 17, 25 and 33 during Injection phase.
|
CAB LA 600 mg - Long-term Follow-up Phase
n=47 participants at risk
After Injection phase, participants were followed-up till Week 89 (long-term follow-up phase).
|
|---|---|---|---|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
3/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
4.3%
2/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
General disorders
Injection site induration
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
8.5%
4/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
General disorders
Injection site pain
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
100.0%
47/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
General disorders
Injection site pruritus
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
6.4%
3/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
General disorders
Injection site swelling
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
46.8%
22/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
General disorders
Pyrexia
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
19.1%
9/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
4.3%
2/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
2.1%
1/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
6.4%
3/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
6.4%
3/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
2.1%
1/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
4/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
31.9%
15/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
19.1%
9/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
6.4%
3/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
2.1%
1/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
6.4%
3/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
4.3%
2/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
8.5%
4/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
3/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
8.5%
4/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
6.4%
3/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
2/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
2.1%
1/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
2.1%
1/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.1%
1/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
4.3%
2/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
4.3%
2/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
1/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
4.3%
2/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
8.5%
4/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Investigations
Blood uric acid increased
|
2.1%
1/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
8.5%
4/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
4.3%
2/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
2/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
2.1%
1/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
0.00%
0/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/48 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
4.3%
2/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
2.1%
1/47 • Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.
AEs and SAEs were collected in the Safety Population for Oral-lead in, Safety injection Population for Injection Phase and long-term follow up phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER