Study to Evaluate Pharmacokinetic (PK), Safety and Tolera... | NCT04484337

NCT04484337

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral Cabotegravir (CAB) 30	Experimental	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.	Drug: Cabotegravir sodium (Oral Lead In)
Part 1: Cohort 1 (C1) CAB 400	Experimental	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	Drug: Cabotegravir sodium (Oral Lead In) Drug: Cabotegravir 400 mg/mL
Part 1: Cohort 1 (C1) CAB200	Active Comparator	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	Drug: Cabotegravir sodium (Oral Lead In) Drug: Cabotegravir 200 mg/mL
Part 1: Cohort 2 (C2) CAB400	Experimental	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cabotegravir sodium (Oral Lead In)	Drug	CAB 30 mg tablets administered orally.	Oral Cabotegravir (CAB) 30 Part 1: Cohort 1 (C1) CAB 400 Part 1: Cohort 1 (C1) CAB200

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part 1 Injection 1: Time of Maximum Observed Plasma Concentration (Tmax) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h	Blood samples were collected for Pharmacokinetic (PK) analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 1 - Day 1 to Week 4
Part 1 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b	Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Day 1 to Week 52 follow-up
Part 2 Injection 1: Tmax for CAB 400 mg/ml Formulation for Cohort 5	Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 1 - Day 1 to Week 12
Part 2 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohort 5	Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Day 1 to Week 52 follow-up
Part 1 Injection 2: Apparent Terminal Phase Half-life (T1/2) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b

Secondary Outcomes

Measure	Description	Time Frame
Part 1 and Part 2: Number of Participants With Adverse Events (AEs) in Injection Phase and Follow up Phase	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The objective of this analysis is to present the data for participants that received at least an intramuscular or subcutaneous study injection of CAB 400 mg/mL or CAB 200 mg/mL with rHuPH20 formulation.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
Participants who are overtly healthy as determined by medical evaluation.
A participant with a clinical abnormality or laboratory parameters which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included if the investigator determines and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Participants who are negative on two consecutive tests for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), performed at Screening and within 5 days of admission to the Phase I unit, using an approved molecular test (Polymerase chain reaction [PCR]).
Body weight more than or equal to (>=)40 kilogram (kg) and body mass index (BMI) within the range 18 to 32 kilogram per square meter (kg/m^2).
Male participants are eligible to participate if they agree to use contraceptive methods and refrain from donating sperm.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percent(%).
Capable of giving signed informed consent.

Exclusion Criteria:

Signs and symptoms which in the opinion of the investigator are suggestive of Coronavirus disease 2019 (COVID-19) (that is [i.e.] fever, cough etc) within 14 days of inpatient admission.
Contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission.
History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
Abnormal blood pressure as determined by the investigator.
Alanine transaminase (ALT) more than (>)1.5 times upper limit of normal (ULN).
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Corrected QT interval (QTc) >450 milliseconds (msec).
A known hypersensitivity to hyaluronidases (Cohort 4h only).
The participant has an underlying skin disease or disorder (infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that would interfere with assessment of injection sites.
Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
Participants considered to have insufficient musculature to allow safe administration of CAB 400 mg/mL (gluteus medius or vastus lateralis).
History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.
History of or on-going high-risk behaviors that may put the participant at increased risk for Human Immunodeficiency Virus (HIV) acquisition in the opinion of the investigator. This includes participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.
Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
A positive pre-study drug/alcohol screen.
Exclusion criteria for screening electrocardiogram (ECG):
1. Heart rate: For Males <45 or >100 beats per minute (bpm), for females <50 or >100 bpm.
2. PR Interval: For males and females <120 or >220 msec.
3. QRS duration: For males and females <70 or >120 msec.
4. QT duration corrected for heart rate by Fridericia's formula (QTcF) interval: For males and females >450 msec.
Evidence of previous myocardial infarction.
Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular [AV] block [2nd degree or higher], Wolff-Parkinson-White [WPW] syndrome).
Sinus Pauses >3 seconds.
Any significant arrhythmia which, in the opinion of the Investigator or GlaxoSmithKline (GSK)/ViiV Medical monitor, will interfere with the safety for the individual participant.
Non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
Positive HIV antibody/antigen test. Participants will be advised regarding safer sex. In the event a participant acquires HIV during the course of the study they will be required to withdraw from the study and will be referred urgently to an HIV treatment center for further management.
Regular use of known drugs of abuse.
Regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
Participants with a history of intolerance to or with contraindications to the use of topical non-steroidal anti-inflammatory drugs (NSAIDs) or topical steroids will be excluded from participation in Cohort 4b.
Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of >14 units for males or >7 units for females.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening.
The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants (gluteal) which may interfere with interpretation of injection site reactions or administration of CAB LA.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	ViiV Healthcare	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Orlando	Florida	32806	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40296638	Derived	Han K, Benn P, Sievers J, Dorey D, Warwick-Sanders M, Hareedy R, Harkness L, Leemereise C, Offenbecker K, Donatti C, Brimhall DB, Schwabe C, Boyle C, Hassman MA, Knowles S, D'Amico R, Spreen WR. A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV. Clin Pharmacol Drug Dev. 2025 Jul;14(7):528-541. doi: 10.1002/cpdd.1538. Epub 2025 Apr 29.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Oral Cabotegravir (CAB) 30	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
FG001	Part 1: Cohort 1 (C1) CAB400

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 28, 2021	May 3, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Drug: Cabotegravir sodium (Oral Lead In)
Drug: Cabotegravir 400 mg/mL

Part 1: Cohort 2 (C2) CAB200

Part 1: Cohort 2 (C2) CAB400

Part 1: Cohort 3 (C3) CAB200

Part 1: Cohort 3 (C3) CAB400

Part 1: Cohort 4 (C4) CAB200

Part 1: Cohort 4 (C4) CAB400

Part 1: Cohort 4b Group 1 (C4b G1)

Part 1: Cohort 4b Group 2 (C4b G2)

Part 1: Cohort 4h (C4h) CAB200 + rHuPH20

Part 1: Cohort 4h (C4h) CAB400 + rHuPH20

Part 2: Cohort 5 (C5) CAB200

Part 2: Cohort 5 (C5) CAB400

Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Oral Cabotegravir (CAB) 30	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
BG001	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
BG002	Part 1: Cohort 1 (C1) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
BG003	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
BG004	Part 1: Cohort 2 (C2) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 300 mg and Injection 2: 200 mg respectively) subcutaneously in the abdomen, 4 weeks apart, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
BG005	Part 1: Cohort 3 (C3) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
BG006	Part 1: Cohort 3 (C3) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
BG007	Part 1: Cohort 4 (C4) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
BG008	Part 1: Cohort 4 (C4) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 400 mg and Injection 2: 100 mg respectively), at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
BG009	Part 1: Cohort 4b Group 1 (C4b G1)	Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
BG010	Part 1: Cohort 4b Group 2 (C4b G2)	Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
BG011	Part 1: Cohort 4h (C4h) CAB400 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.
BG012	Part 1: Cohort 4h (C4h) CAB200 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
BG013	Part 2: Cohort 5 (C5) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
BG014	Part 2: Cohort 5 (C5) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.
BG015	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

De-identified

Title	Measurements
	BG00011 BG00117 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Part 1 Injection 1: Time of Maximum Observed Plasma Concentration (Tmax) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h

Blood samples were collected for Pharmacokinetic (PK) analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.

PK population included all participants in the Safety population (all participants who received at least one dose of study treatment (oral or injection)) who received study treatment and had at least 1 non-missing PK assessment (non-quantifiable [NQ] values will be considered as non-missing values). Only those participants with data available at specified time points have been analyzed. For Part 1: Cohort 3 (C3) CAB400 [1] group, 2 participants received 400 mg instead of 600 mg for Injection 1.

Posted

Mean

Standard Deviation

Hour (h)

Injection 1 - Day 1 to Week 4

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 3 (C3) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG003	Part 1: Cohort 4 (C4) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.
OG004	Part 1: Cohort 4b Group 1 (C4b G1)	Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.
OG005	Part 1: Cohort 4b Group 2 (C4b G2)	Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.
OG006	Part 1: Cohort 4h (C4h) CAB400 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.

Units	Counts
Participants	OG00018 OG0018 OG00213 OG003

Title	Denominators	Categories
Injection 1	ParticipantsOG00018 ParticipantsOG0018 ParticipantsOG00211 ParticipantsOG003

Primary

Part 1 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b

Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Mean

Standard Deviation

Hour (h)

Injection 2 - Day 1 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 3 (C3) CAB400

Primary

Part 2 Injection 1: Tmax for CAB 400 mg/ml Formulation for Cohort 5

Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.

PK population.

Posted

Mean

Standard Deviation

Hour (h)

Injection 1 - Day 1 to Week 12

ID	Title	Description
OG000	Part 2: Cohort 5 (C5) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.

Units	Counts
Participants	OG000

Primary

Part 2 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohort 5

PK population. There were no participants that received the second injection in C5.

Posted

Injection 2 - Day 1 to Week 52 follow-up

ID	Title	Description
OG000	Part 2: Cohort 5 (C5) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.

Units	Counts
Participants	OG000

Primary

Part 1 Injection 2: Apparent Terminal Phase Half-life (T1/2) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour (h)

Injection 2 - Week 4 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002

Primary

Part 2 Injection 2: T1/2 for CAB 400 mg/ml Formulation for Cohort 5

PK population. There were no participants that received the second injection in C5.

Posted

Injection 2 - Week 12 to Week 52 follow-up

ID	Title	Description
OG000	Part 2: Cohort 5 (C5) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.

Units	Counts
Participants	OG000

Primary

Part 1 Injection 2: Terminal Absorption Elimination Rate Constant (KALA) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b

KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected at indicated time points. PK parameters were determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

1/h

Injection 2 - Week 4 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Primary

Part 2 Injection 2: KALA for CAB 400 mg/ml Formulation for Cohort 5

PK population. There were no participants that received the second injection in C5.

Posted

Injection 2 - Week 12 to Week 52 follow-up

ID	Title	Description
OG000	Part 2: Cohort 5 (C5) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.

Units	Counts
Participants	OG000

Primary

Part 1 Injection 1: Plasma Trough Concentrations (Ctau) of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h

Blood samples were collected for PK analysis of CAB. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR studies.

PK population. Only those participants with data available at specified time points have been analyzed. In the "Part 1: Cohort 3 (C3) CAB400" group, 2 participants received 400 mg instead of 600 mg for Injection 1 [1].

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram/ millilitre (μg/mL)

Injection 1 - Day 1 to Week 4

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Primary

Part 1 Injection 2: Ctau of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Injection 2 - Day 1 to Week 4

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Primary

Part 2 Injection 1: Ctau of CAB 400 mg/ml Formulation for Cohort 5

Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. Ctau is the trough concentration at the end of the dosing interval. Ctau was expressed as geometric mean. For ATLAS /FLAIR: Historical data of CAB200 group, the geometric mean following dose normalization to 800mg was presented. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR and ECLAIRE studies.

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Injection 1 - Day 1 to Week 12

ID	Title	Description
OG000	Part 2: Cohort 5 (C5) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.
OG001	ATLAS /FLAIR: Historical Data of CAB200	Historical data from HIV-1 infected adult participants in Phase III studies ATLAS [NCT02951052] and FLAIR [NCT02938520] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.

Primary

Part 1 Injection 1: Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Time Point (AUC(0-t)) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h

Blood samples were collected for PK analysis of CAB. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*μg/mL

Injection 1 - Day 1 to Week 4

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Primary

Part 1 Injection 2: AUC(0-t) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4 and 4b

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*μg/mL

Injection 2 - Day 1 to Week 4

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 3 (C3) CAB400

Primary

Part 1 Injection 1: Maximum Observed Plasma Concentration (Cmax) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h

The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.

PK population. Only those participants with data available at specified time points have been analyzed. For Part 1: Cohort 3 (C3) CAB400 [1] group, 2 participants received 400 mg instead of the 600 mg for Injection 1.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Injection 1 - Day 1 to Week 4

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002

Primary

Part 1 Injection 2: Cmax of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b

The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Injection 2 - Day 1 to Week 4

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 3 (C3) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Secondary

Part 1 and Part 2: Number of Participants With Adverse Events (AEs) in Injection Phase and Follow up Phase

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

The objective of this analysis is to present the data for participants that received at least an intramuscular or subcutaneous study injection of CAB 400 mg/mL or CAB 200 mg/mL with rHuPH20 formulation.

Safety population included all participants who received at least one dose of study treatment (oral or injection). In the "Part 1: Cohort 3 (C3) CAB400" group, 2 participants received 400 mg instead of 600 mg of CAB for Injection 1, therefore, the number of participants with AEs, for the 2 participants that received 400 mg of CAB for injection 1, is presented, separately, on "Injection 1 [1]" row in the below table.

Posted

Count of Participants

Participants

From Injection 1 day 1 up to 52 weeks follow-up

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Secondary

Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase

Blood samples were collected at indicated timepoints to analyze the liver biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin and Direct Bilirubin.

Safety population included all participants who received at least one dose of study treatment (oral or injection). In the "Part 1: Cohort 3 (C3) CAB400" group, 2 participants received 400 mg instead of 600 mg of CAB for Injection 1, therefore, the number of participants with liver biochemistry abnormalities, for the 2 participants that received 400 mg of CAB for injection 1, is presented, separately, on "Injection 1 [1]" row, for each parameter analyzed, in the below table.

Posted

Count of Participants

Participants

From Injection 1 day 1 up to 52 weeks follow-up

ID	Title	Description
OG000	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG001	Part 1: Cohort 2 (C2) CAB400

Secondary

Cmax for CAB Following Oral 30 mg Administration

Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods.

PK population. Only those participants with data available at specified time points have been analyzed. The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12)

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Up to Day 29

ID	Title	Description
OG000	Oral Cabotegravir (CAB) 30	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
OG001	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 1 (C1) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Secondary

Tmax for CAB Following Oral 30 mg Administration

Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods.

PK population. Only those participants with data available at specified time points have been analyzed.The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12).

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour (h)

Up to Day 29

ID	Title	Description
OG000	Oral Cabotegravir (CAB) 30	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
OG001	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 1 (C1) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Secondary

AUC(0-t) for CAB Following Oral 30 mg Administration

Blood samples were collected for PK analysis of CAB after subcutaneous administration. The PK parameters were calculated by non-compartmental analysis.

PK population. Only those participants with data available at specified time points have been analyzed.The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12).

Posted

Geometric Mean

Geometric Coefficient of Variation

h*μg/mL

Up to Day 29

ID	Title	Description
OG000	Oral Cabotegravir (CAB) 30	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
OG001	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 1 (C1) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Secondary

Concentration at 24 Hours (C24) for CAB Following Oral 30 mg Administration

PK population. Only those participants with data available at specified time points have been analyzed.The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12)

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

At 24 hours

ID	Title	Description
OG000	Oral Cabotegravir (CAB) 30	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
OG001	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 1 (C1) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Secondary

Ctau for CAB Following Oral 30 mg Administration

PK population. Only those participants with data available at specified time points have been analyzed.The results for Oral Cabotegravir (CAB) 30 mg group includes those participants that received CAB during OLI phase but did not enter the injection phase (N=12)

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Up to 24 hours on day 29 (Oral lead in phase)

ID	Title	Description
OG000	Oral Cabotegravir (CAB) 30	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.
OG001	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.
OG002	Part 1: Cohort 1 (C1) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.

Secondary

Cmax of CAB 200 for Cohort 4h

Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameter was determined using standard non-compartmental methods.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Injection 1 - Day 1 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 4h (C4h) CAB200 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.

Units	Counts
Participants	OG000

Secondary

Tmax of CAB 200 for Cohort 4h

Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameter was determined using standard non-compartmental methods.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour (h)

Injection 1 - Day 1 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 4h (C4h) CAB200 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.

Units	Counts
Participants	OG000

Secondary

AUC(0-t) of CAB 200 for Cohort 4h

Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameters were determined using standard non-compartmental methods.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*μg/mL

Injection 1 - Day 1 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 4h (C4h) CAB200 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.

Units	Counts
Participants	OG000

Secondary

Ctau of CAB 200 for Cohort 4h and in ATLAS/FLAIR Study

Blood samples were collected for PK analysis of CAB after subcutaneous administration. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. Ctau was expressed as geometric mean. For ATLAS /FLAIR: Historical data of CAB200 group, the geometric mean following dose normalization to 400mg was presented.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Injection 1 - Day 1 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 4h (C4h) CAB200 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
OG001	ATLAS /FLAIR: Historical Data of CAB200	Historical data from HIV-1 infected adult participants in Phase III studies ATLAS [NCT02951052] and FLAIR [NCT02938520] combined who received oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by intra-muscular (IM) injections of 600mg of CAB200 (CAB 200 mg/mL) and RPV LA (900 mg) at Week 4b, then monthly IM injections of 400 mg of CAB200 (CAB 200 mg/mL) + RPV LA (600 mg) from Week 8 until study completion or withdrawal.

Secondary

T1/2 of CAB 200 & CAB 400 for Cohort 4h

Blood samples were collected for PK analysis of CAB after subcutaneous administration. The PK parameters were calculated by non-compartmental analysis.

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hour (h)

Injection 1 - Day 1 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 4h (C4h) CAB200 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
OG001	Part 1: Cohort 4h (C4h) CAB400 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.

Units	Counts
Participants

Secondary

KALA of CAB 200 & CAB 400 for Cohort 4h

KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameters were determined using standard non-compartmental methods.

PK population. Only those participants with data available at specified time points have been analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

1/h

Injection 1 - Day 1 to Week 52 follow-up

ID	Title	Description
OG000	Part 1: Cohort 4h (C4h) CAB200 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.
OG001	Part 1: Cohort 4h (C4h) CAB400 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Oral Cabotegravir (CAB) 30	Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.	13	0	13	4	13
EG001	Part 1: Cohort 1 (C1) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	18	0	18	18	18
EG002	Part 1: Cohort 1 (C1) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	2	0	2	2	2
EG003	Part 1: Cohort 2 (C2) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	11	0	11	10	11
EG004	Part 1: Cohort 2 (C2) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 300 mg and Injection 2: 200 mg respectively) subcutaneously in the abdomen, 4 weeks apart, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	1	0	1	1	1
EG005	Part 1: Cohort 3 (C3) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	16	2	16	15	16
EG006	Part 1: Cohort 3 (C3) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	2	0	2	2	2
EG007	Part 1: Cohort 4 (C4) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.	18	0	18	18	18
EG008	Part 1: Cohort 4 (C4) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 400 mg and Injection 2: 100 mg respectively), at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.	2	0	2	1	2
EG009	Part 1: Cohort 4b Group 1 (C4b G1)	Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.	13	0	13	13	13
EG010	Part 1: Cohort 4b Group 2 (C4b G2)	Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.	14	1	14	13	14
EG011	Part 1: Cohort 4h (C4h) CAB400 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.	9	0	9	9	9
EG012	Part 1: Cohort 4h (C4h) CAB200 + rHuPH20	Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.	8	0	8	8	8
EG013	Part 2: Cohort 5 (C5) CAB400	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.	10	0	10	10	10
EG014	Part 2: Cohort 5 (C5) CAB200	Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.	1	0	1	1	1

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG0030 events0 affected11 at risk EG004
Anxiety	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Decreased appetite	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG0030 events0 affected11 at risk EG0040 events0 affected1 at risk EG0050 events0 affected16 at risk EG0060 events0 affected2 at risk EG0071 events1 affected18 at risk EG0080 events0 affected2 at risk EG0090 events0 affected13 at risk EG0100 events0 affected14 at risk EG0110 events0 affected9 at risk EG0120 events0 affected8 at risk EG0130 events0 affected10 at risk EG0140 events0 affected1 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Headache	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0012 events2 affected18 at risk EG0020 events0 affected2 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0013 events2 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site pain	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG00132 events18 affected18 at risk EG0022 events2 affected2 at risk EG003
Injection site nodule	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG00112 events10 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site erythema	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG00111 events8 affected18 at risk EG0021 events1 affected2 at risk EG003
Injection site induration	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0018 events6 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site warmth	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0015 events5 affected18 at risk EG0020 events0 affected2 at risk EG003
Fatigue	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site swelling	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected18 at risk EG0020 events0 affected2 at risk EG003
Chills	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site bruising	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site discomfort	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site oedema	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site pruritus	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Pyrexia	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0013 events3 affected18 at risk EG0021 events1 affected2 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0021 events1 affected2 at risk EG003
Haematocrit decreased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Haemoglobin decreased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Lymph node palpable	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Red blood cell count decreased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Dizziness	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Somnolence	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Abnormal dreams	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site haemorrhage	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
COVID-19	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Oedema	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Presyncope	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Body temperature increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Anxiety	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Depression	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Influenza like illness	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Catheter site bruise	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Catheter site erythema	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Feeling cold	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Feeling hot	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Feeling of body temperature change	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Medical device site dermatitis	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Vaccination site pain	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Vessel puncture site bruise	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Lethargy	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Muscle contractions involuntary	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Skin induration	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
White blood cell count increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Ear disorder	Ear and labyrinth disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Burnout syndrome	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Insomnia	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Osteoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Hot flush	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Application site plaque	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site discolouration	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site dryness	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site papule	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Malaise	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Post inflammatory pigmentation change	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Vision blurred	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Application site pruritus	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Application site rash	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Injection site exfoliation	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Hordeolum	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Barrett's oesophagus	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Eye pruritus	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Flushing	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Axillary pain	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Administration site discolouration	General disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Neutrophil count increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Otitis media	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Pallor	Vascular disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Faeces pale	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected18 at risk EG0020 events0 affected2 at risk EG003

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
C584914	cabotegravir
D007854	Lead
D000894	Anti-Inflammatory Agents, Non-Steroidal
D013256	Steroids

Ancestor Terms

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals
D018712	Analgesics, Non-Narcotic
D000700	Analgesics
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D000893	Anti-Inflammatory Agents
D045506	Therapeutic Uses
D018501	Antirheumatic Agents
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Units	Counts
Participants	OG0008 OG001501

EG0052 events1 affected16 at risk

EG0060 events0 affected2 at risk

EG0070 events0 affected18 at risk

EG0080 events0 affected2 at risk

EG0090 events0 affected13 at risk

EG0100 events0 affected14 at risk

EG0110 events0 affected9 at risk

EG0120 events0 affected8 at risk

EG0130 events0 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG0051 events1 affected16 at risk

EG0060 events0 affected2 at risk

EG0070 events0 affected18 at risk

EG0080 events0 affected2 at risk

EG0090 events0 affected13 at risk

EG0100 events0 affected14 at risk

EG0110 events0 affected9 at risk

EG0120 events0 affected8 at risk

EG0130 events0 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG0050 events0 affected16 at risk

EG0060 events0 affected2 at risk

EG0070 events0 affected18 at risk

EG0080 events0 affected2 at risk

EG0090 events0 affected13 at risk

EG0101 events1 affected14 at risk

EG0110 events0 affected9 at risk

EG0120 events0 affected8 at risk

EG0130 events0 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG0050 events0 affected16 at risk

EG0060 events0 affected2 at risk

EG0070 events0 affected18 at risk

EG0080 events0 affected2 at risk

EG0090 events0 affected13 at risk

EG0100 events0 affected14 at risk

EG0110 events0 affected9 at risk

EG0120 events0 affected8 at risk

EG0130 events0 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG00512 events6 affected16 at risk

EG0060 events0 affected2 at risk

EG00726 events14 affected18 at risk

EG0080 events0 affected2 at risk

EG0095 events5 affected13 at risk

EG0108 events5 affected14 at risk

EG0114 events3 affected9 at risk

EG0121 events1 affected8 at risk

EG0136 events6 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG0050 events0 affected16 at risk

EG0060 events0 affected2 at risk

EG0073 events2 affected18 at risk

EG0080 events0 affected2 at risk

EG0091 events1 affected13 at risk

EG0103 events2 affected14 at risk

EG0110 events0 affected9 at risk

EG0120 events0 affected8 at risk

EG0131 events1 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG0050 events0 affected16 at risk

EG0060 events0 affected2 at risk

EG0075 events5 affected18 at risk

EG0080 events0 affected2 at risk

EG0091 events1 affected13 at risk

EG0100 events0 affected14 at risk

EG0110 events0 affected9 at risk

EG0120 events0 affected8 at risk

EG0130 events0 affected10 at risk

EG0140 events0 affected1 at risk

EG0041 events1 affected1 at risk

EG00520 events12 affected16 at risk

EG0064 events2 affected2 at risk

EG00733 events17 affected18 at risk

EG0081 events1 affected2 at risk

EG00927 events12 affected13 at risk

EG01024 events12 affected14 at risk

EG01111 events9 affected9 at risk

EG0128 events8 affected8 at risk

EG01310 events10 affected10 at risk

EG0141 events1 affected1 at risk

EG0041 events1 affected1 at risk

EG0052 events1 affected16 at risk

EG0060 events0 affected2 at risk

EG00713 events9 affected18 at risk

EG0080 events0 affected2 at risk

EG00912 events7 affected13 at risk

EG0108 events5 affected14 at risk

EG0112 events2 affected9 at risk

EG0120 events0 affected8 at risk

EG0132 events2 affected10 at risk

EG0141 events1 affected1 at risk

EG0040 events0 affected1 at risk

EG0056 events4 affected16 at risk

EG0061 events1 affected2 at risk

EG00726 events18 affected18 at risk

EG0082 events1 affected2 at risk

EG00920 events12 affected13 at risk

EG01022 events12 affected14 at risk

EG0119 events9 affected9 at risk

EG0128 events8 affected8 at risk

EG0134 events4 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG0055 events3 affected16 at risk

EG0062 events2 affected2 at risk

EG00710 events8 affected18 at risk

EG0081 events1 affected2 at risk

EG0093 events3 affected13 at risk

EG0103 events2 affected14 at risk

EG0110 events0 affected9 at risk

EG0121 events1 affected8 at risk

EG0130 events0 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG0053 events3 affected16 at risk

EG0060 events0 affected2 at risk

EG00711 events10 affected18 at risk

EG0080 events0 affected2 at risk

EG00917 events12 affected13 at risk

EG01018 events11 affected14 at risk

EG0118 events8 affected9 at risk

EG0126 events6 affected8 at risk

EG0136 events6 affected10 at risk

EG0140 events0 affected1 at risk

EG0040 events0 affected1 at risk

EG0050 events0 affected16 at risk

EG0060 events0 affected2 at risk

EG0074 events3 affected18 at risk