Pharmacokinetic Study of Cabotegravir Long-acting in Heal... | NCT02478463

Label	Type	Description	Intervention Names
Cabotegravir	Experimental	Subject will receive CAB 30 mg tablet once daily oral dose for 28 days (4 weeks) followed by a washout period of 14 to 42 days. After the washout, subject will receive a single dose of CAB LA 600 mg IM to gluteal region.	Drug: Cabotegravir tablet 30 mg once daily for 28 days. Drug: Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.

Name	Type	Description	Arm Group Labels	Other Names
Cabotegravir tablet 30 mg once daily for 28 days.	Drug	GSK1265744B, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, Aquarius film-coating, white BP18237

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cabotegravir Concentration in Blood Plasma Following IM Administration	Blood samples were collected to measure cabotegravir concentration in blood plasma following a single 600 mg IM dose at indicated time-points. Evaluable Pharmacokinetic (PK) Plasma Parameter Summary Population comprised of all participants who underwent plasma PK sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and had evaluable PK parameters estimated and no major protocol deviation.	Day 1: Pre-dose and 4 hours; one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36 and 52 post-dose
Cabotegravir Concentration in Vaginal Tissue Following IM Administration (Female Participants)	Vaginal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM) comprised of all participants who underwent sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and have both evaluable PK and evaluable tissues-fluid parameters estimated in vaginal tissue/cervical tissue/cervicovaginal fluid/rectal tissue/rectal fluid.	One sample on Day 3 and Week 8 post-dose
Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants)	Cervical tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.	One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)	Cervicovaginal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.	One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Cabotegravir Concentration in Rectal Tissue Following IM Administration

Secondary Outcomes

Measure	Description	Time Frame
Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)	Vaginal tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in vaginal tissue to cabotegravir concentration in blood plasma is presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the medical monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat of a procedure or lab parameter is allowed to determine eligibility.
Body weight >= 40 kilogram (kg) and body mass index (BMI) within the range 18.5 to 35 kg /meter square (inclusive).
Male or female
A female subject is eligible to participate if she is pre-menopausal, has an intact uterus and cervix, AND is not pregnant (as confirmed by a negative human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: a) Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Documented Bilateral Oophorectomy. b)Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer (can be up to 66 weeks on study) after the last dose of study medication and completion of the follow-up visit. Female subjects desiring pregnancy or foresee that they might wish to become pregnant within 52 weeks of receiving a CAB LA injection must be excluded. All subjects participating in the study must be counseled on safe sexual practices including the use of effective barrier methods to minimize risk of HIV transmission.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion Criteria:

Liver Function: ALT or AST > upper limit of normal (ULN)
Total bilirubin >ULN (isolated total bilirubin >ULN is acceptable if total 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 (QTc) Interval: QTc > 450 milliseconds (msec):

NOTES: The QTc is the QT interval corrected for heart rate according to Bazette's formula (QTcB), machine-read or manually over-read. QTcB will be used to determine eligibility for an individual subject. Exclusion criteria for screening electrocardiogram (ECG) (a single repeat is allowed for eligibility determination): Heart rate (<45 and >100 beats per minute (bpm) for males and <50 and >100 bpm for females; QRS duration: >120 msec; QTc interval: >450 msec for males and females

The subject's systolic blood pressure is outside the range of 90-140 millimeter (mm) mercury (Hg), or diastolic blood pressure is outside the range of 45-90 mmHg.
History of clinically significant cardiovascular disease including:

Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization); History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease; Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block (2nd degree [type II] or higher), Wolf Parkinson White [WPW] syndrome); Sinus pauses > 3 seconds.

Any significant arrhythmia which, in the opinion of the principal Investigator and GSK Medical Monitor, will interfere with the safety for the individual subject. Non-sustained (>=3 consecutive ventricular ectopic beats) or sustained ventricular tachycardia.
History of ongoing or clinically relevant seizure disorder within the previous 2 years, including subjects who have required treatment for seizures within this time period. A prior history of seizure, with a seizure free period of at least 2 years, off anti-epileptics, may be considered for enrolment if the investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the medical monitor prior to enrolment
Use of any concurrent prohibited medications as outlined in protocol
History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
Inability or unwillingness to comply with lifestyle and/or dietary restrictions outlined in protocol.
High-risk behavior for HIV infection which includes, but is not limited to, one of the following risk factors within six months before entering the study (Day 1 of the oral lead-in): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months or intravenous drug use.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
For subjects participating in magnetic resonance imaging (MRI) imaging: Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other non-MRI compatible metallic objects; b) Intra- orbital metal fragments that have not been removed by a medical professional; c) Pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves, d) Inner ear implants, e) History of claustrophobia
Positive hepatitis B surface antigen or positive hepatitis B core antibody with negative hepatitis B surface antibody test result at screening or within 3 months prior to first dose of study treatment.
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. A positive drug screen is permitted if due to a prescribed medication, provided that medication is not on the list of prohibited medications and approved by the investigator and medical monitor.
A positive test for HIV antibody.
A positive pre-study screen for sexually transmitted diseases including Neisseria gonorrhea or Chlamydia trachomatis, Trichomonas, syphilis, or an active Herpes simplex virus (HSV) genital lesion.
Presence of a tattoo or other dermatological condition overlying the buttocks which in the opinion of the investigator may interfere with the interpretation of injection site reactions.
The subject 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.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.

Additional Criteria for Female Subjects Only:

Any current medical conditions that in the opinion of the investigator may compromise the conduct or analysis of the genital tract sampling (e.g., active genital tract infection or lesions).
Inability to abstain from the use of intravaginal products (e.g. tampons, spermicides, lubricants, vaginal hygiene products, diaphragms) for 72 hours prior to the genital tract sample collection visits and for up to 72 hours after.
Inability to abstain from any sexual activity (e.g., vaginal intercourse, masturbation, and penetration of the vagina by penises, fingers, tampons, sex toys) for 72 hours prior to the genital tract sample collection visits and for up to 72 hours after.

Additional Criteria for Male Subjects and Female Subjects who consent to rectal PK sampling:

Any current medical conditions that in the opinion of the investigator may compromise the conduct or analysis of the rectal compartment sampling (e.g., active rectal compartment infection, lesions or disease).
Inability to abstain from the use of intrarectal products (e.g., suppositories, lubricants) for 72 hours prior to the rectal compartment sample collection visits and for up to 72 hours after.
Inability to abstain from any receptive anal sexual activity (e.g., anal receptive intercourse and penetration of the rectum by fingers, sex toys or other) for 72 hours prior to the rectal compartment sample collection visit and for up to 72 hours after.

Name	Affiliation	Role
GSK Clinical Trials	ViiV Healthcare	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Baltimore	Maryland	21287-5554	United States
GSK Investigational Site

ID	Title	Description
FG000	Cabotegravir Oral 30 mg Followed by Cabotegravir IM 600 mg	Participants received once daily oral dose of 30 milligram (mg) cabotegravir for 28 days during the oral lead-in phase in Period 1 followed by a single intramuscular (IM) dose of 600 mg cabotegravir in Period 2. There was a washout period of up to 42 days between the two treatment periods.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Aug 14, 2019	May 12, 2020

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

Cabotegravir Concentration in Blood Plasma Following IM Administration

Blood samples were collected to measure cabotegravir concentration in blood plasma following a single 600 mg IM dose at indicated time-points. Evaluable Pharmacokinetic (PK) Plasma Parameter Summary Population comprised of all participants who underwent plasma PK sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and had evaluable PK parameters estimated and no major protocol deviation.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Micrograms per milliliter

Day 1: Pre-dose and 4 hours; one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36 and 52 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG00015

Title

Denominators

Categories

Day 1: Pre-dose, n=15

- ParticipantsOG00015

Title	Measurements
	OG0000.0000± NANA indicates that standard deviation could not be calculated due to high proportion of non-quantifiable (NQ) values (more than 30% values were imputed i.e. NQ assigned zero concentration) which affected the calculation.

Day 1: 4 hours, n=15

- ParticipantsOG000

Primary

Cabotegravir Concentration in Vaginal Tissue Following IM Administration (Female Participants)

Vaginal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM) comprised of all participants who underwent sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and have both evaluable PK and evaluable tissues-fluid parameters estimated in vaginal tissue/cervical tissue/cervicovaginal fluid/rectal tissue/rectal fluid.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

One sample on Day 3 and Week 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Primary

Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants)

Cervical tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Primary

Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Primary

Cabotegravir Concentration in Rectal Tissue Following IM Administration

Rectal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Primary

Cabotegravir Concentration in Rectal Fluid Following IM Administration

Rectal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)

Vaginal tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in vaginal tissue to cabotegravir concentration in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Day 3 and Week 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)

Cervical tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervical tissue to cabotegravir concentration in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)

Cervicovaginal fluid and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervicovaginal fluid to cabotegravir concentration in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervical tissue and cervicovaginal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervical tissue to cabotegravir concentration in cervicovaginal fluid is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Day 3, 8, Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)

Vaginal tissue and cervicovaginal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in vaginal tissue to cabotegravir concentration in cervicovaginal fluid is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Day 3 and Week 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration

Rectal tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal tissue to cabotegravir concentration in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration

Rectal fluid and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal fluid to cabotegravir concentration in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration

Rectal tissue and rectal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal tissue to cabotegravir concentration in rectal fluid is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Concentration (Cmax) of Cabotegravir in Blood Plasma Following IM Administration

Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Cmax of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

Cervical tissue samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Cmax of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Cmax of Cabotegravir in Rectal Tissue Following IM Administration

Rectal tissue samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Cmax of Cabotegravir in Rectal Fluid Following IM Administration

Rectal fluid samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Micrograms per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Time Point (AUC[0-last]) for Cabotegravir in Blood Plasma Following IM Administration

Blood samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

Day 1: Pre-dose, 4 hours, One sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-last) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

Cervical tissue samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-last) of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-last) for Cabotegravir in Rectal Tissue Following IM Administration

Rectal tissue samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-last) for Cabotegravir in Rectal Fluid Following IM Administration

Rectal fluid samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-inf]) for Cabotegravir in Blood Plasma Following IM Administration

Blood samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-inf) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

Cervical tissue samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-inf) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-inf) for Cabotegravir in Rectal Tissue Following IM Administration

Rectal tissue samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-inf) for Cabotegravir in Rectal Fluid Following IM Administration

Rectal fluid samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration Time Curve From Time Zero to Week (WK) 4 (AUC[0-WK4]) for Cabotegravir in Blood Plasma Following IM Administration

Blood samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK4) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

Cervical tissue samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK4) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK4) for Cabotegravir in Rectal Tissue Following IM Administration

Rectal tissue samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK4) for Cabotegravir in Rectal Fluid Following IM Administration

Rectal fluid samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration Time Curve From Time Zero to Week 8 (AUC[0-WK8]) for Cabotegravir in Blood Plasma Following IM Administration

Blood samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK8) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

Cervical tissue samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK8) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK8) for Cabotegravir in Rectal Tissue Following IM Administration

Rectal tissue samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK8) for Cabotegravir in Rectal Fluid Following IM Administration

Rectal fluid samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration Time Curve From Time Zero to Week 12 (AUC[0-WK12]) for Cabotegravir in Blood Plasma Following IM Administration

Blood samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK12) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

Cervical tissue samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK12) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK12) for Cabotegravir in Rectal Tissue Following IM Administration

Rectal tissue samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

AUC(0-WK12) for Cabotegravir in Rectal Fluid Following IM Administration

Rectal fluid samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*microgram per milliliter

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Apparent Terminal Phase Half-life (t1/2) of Cabotegravir in Blood Plasma Following IM Administration

Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

t1/2 of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

Cervical tissue samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

t1/2 of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

t1/2 of Cabotegravir in Rectal Tissue Following IM Administration

Rectal tissue samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

t1/2 of Cabotegravir in Rectal Fluid Following IM Administration

Rectal fluid samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-last) in Cervical Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervical tissue and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in cervical tissue to AUC(0-last) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-last) in Rectal Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration

Rectal tissue and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in rectal tissue to AUC(0-last) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-inf) in Cervical Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervical tissue and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in cervical tissue to AUC(0-inf) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-inf) in Rectal Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration

Rectal tissue and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in rectal tissue to AUC(0-inf) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-Wk4) in Cervical Tissue to AUC(0-Wk4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervical tissue and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in cervical tissue to AUC(0-WK4) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-Wk 4) in Rectal Tissue to AUC(0-Wk 4) in Blood Plasma for Cabotegravir Following IM Administration

Rectal tissue and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in rectal tissue to AUC(0-WK4) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK8) in Cervical Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervical tissue and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in cervical tissue to AUC(0-WK8) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK8) in Rectal Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration

Rectal tissue and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in rectal tissue to AUC(0-WK8) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK12) in Cervical Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervical tissue and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in cervical tissue to AUC(0-WK12) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK12) in Rectal Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration

Rectal tissue and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in rectal tissue to AUC(0-WK12) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-last) in Cervicovaginal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration-female Participants

Cervicovaginal fluid and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in cervicovaginal fluid to AUC(0-last) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-last) in Rectal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration

Rectal fluid and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in rectal fluid to AUC(0-last) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-inf) in Cervicovaginal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervicovaginal fluid and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in cervicovaginal fluid to AUC(0-inf) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-inf) in Rectal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration

Rectal fluid and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in rectal fluid to AUC(0-inf) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK4) in Cervicovaginal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in cervicovaginal fluid to AUC(0-WK4) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK4) in Rectal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration

Rectal fluid and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in rectal fluid to AUC(0-WK4) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8 and Week 4 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK8) in Cervicovaginal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in cervicovaginal fluid to AUC(0-WK8) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK8) in Rectal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration

Rectal fluid and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in rectal fluid to AUC(0-WK8) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4 and 8 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK12) in Cervicovaginal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in cervicovaginal fluid to AUC(0-WK12) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Ratio of AUC(0-WK12) in Rectal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration

Rectal fluid and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in rectal fluid to AUC(0-WK12) in blood plasma is presented.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio

One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Cabotegravir Concentration in Vaginal Tissue Following Oral Administration (Female Participants)

Vaginal tissue samples were collected to measure cabotegravir concentration in vaginal tissue following oral 30 mg dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

24 hours post-dose on Day 28

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Cabotegravir Concentration in Cervical Tissue Following Oral Administration (Female Participants)

Cervical tissue samples were collected to measure cabotegravir concentration in cervical tissue following oral 30 mg dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

24 hours post-dose on Day 28

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Cabotegravir Concentration in Cervicovaginal Fluid Following Oral Administration (Female Participants)

Cervicovaginal fluid samples were collected to measure cabotegravir concentration in cervicovaginal fluid following oral 30 mg dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

24 hours post-dose on Day 28

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Cabotegravir Concentration in Rectal Tissue Following Oral Administration

Rectal tissue samples were collected to measure cabotegravir concentration in rectal tissue following oral 30 mg dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

24 hours post-dose on Day 28

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Cabotegravir Concentration in Rectal Fluid Following Oral Administration

Rectal fluid samples were collected to measure cabotegravir concentration in rectal fluid following oral 30 mg dose at indicated time-points.

Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

24 hours post-dose on Day 28

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Cabotegravir Concentration in Blood Plasma Following Oral Administration

Blood samples were collected to measure cabotegravir concentration in blood plasma following oral 30 mg dose at indicated time-points.

Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Micrograms per milliliter

24 hours post-dose on Day 28

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Serious Adverse Events (SAE) Following Oral Administration of Cabotegravir

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment, associated with liver injury and impaired liver function was categorized as SAE. Number of participants with any non-SAE and SAE are presented.

Safety Population comprised of all participants who received at least one dose of study drug.

Posted

Count of Participants

Participants

Up to Day 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Any Non-SAE and SAE Following IM Administration of Cabotegravir

Safety Population

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of clinical chemistry parameters; ALT, ALP and AST following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

International units per Liter

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of clinical chemistry parameters; ALT, ALP and AST following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

International units per Liter

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Creatine Kinase at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of clinical chemistry parameter; creatine kinase following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

International units per Liter

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Creatine Kinase at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of clinical chemistry parameter; creatine kinase following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

International units per Liter

Baseline (Day 1, Pre-dose), Weeks 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of clinical chemistry parameters; creatinine, direct bilirubin and total bilirubin following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Micromoles per liter

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of clinical chemistry parameters; creatinine, direct bilirubin and total bilirubin following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Micromoles per liter

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of clinical chemistry parameters; albumin and total protein following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Grams per liter

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of clinical chemistry parameters; albumin and total protein following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Grams per liter

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of clinical chemistry parameters; calcium, glucose, potassium, sodium and urea enzymatic colorimetry (UEC) following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Millimoles per Liter

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of clinical chemistry parameters; calcium, glucose, potassium, sodium and UEC following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Millimoles per Liter

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of hematology parameters; basophil count, eosinophil count, lymphocyte count and monocyte count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Giga cells per Liter

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of hematology parameters; basophil count, eosinophil count, lymphocyte count and monocyte count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Giga cells per Liter

Baseline (Day 1, Pre-dose), Weeks 4 and 8

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total Neutrophil Count at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of hematology parameter; total neutrophils count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Giga cells per Liter

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of hematology parameters; total neutrophil count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Giga cells per Liter

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of hematology parameters; platelet count and WBC count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Giga cells per Liter

Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of hematology parameters; platelet count and WBC count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Giga cells per Liter

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of hematology parameters; hemoglobin and MCHC following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Grams per Liter

Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of hematology parameters; hemoglobin and MCHC following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Grams per Liter

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of hematology parameter; MCH following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Picograms

Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in MCH at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of hematology parameter; MCH following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Picograms

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of hematology parameter; MCV following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Femtoliters

Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in MCV at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of hematology parameter; MCV following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Femtoliters

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of hematology parameter; hematocrit following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Proportion of red blood cells in blood

Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Hematocrit at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of hematology parameter; hematocrit following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Proportion of red blood cells in blood

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose)

Blood samples were collected for the assessment of hematology parameter; RBC count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Trillion cells per liter

Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in RBC Count at Indicated Time Points (IM Dose)

Blood samples were collected for the assessment of hematology parameter; RBC count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Trillion cells per liter

Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose)

SBP and DBP were measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Millimeters of mercury

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Millimeters of mercury

Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Pulse Rate at Indicated Time Points (Oral Dose)

Pulse rate was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Beats per minute

Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Temperature at Indicated Time Points (Oral Dose)

Body temperature was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

Safety Population. Only those participants with data available at the specified data points were analyzed.

Posted

Mean

Standard Deviation

Degrees Celsius

Baseline (Day 1, Pre-dose), Days 14 and 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Degrees Celsius

Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Abnormal Urinalysis Parameters Following Oral Administration of Cabotegravir

Urinalysis included assessment of pH, glucose, protein, blood and ketones by dipstick method. This analysis was not planned and data was not collected and not captured in the database.

Safety Population. This analysis was not planned and data was not collected and not captured in the database.

Posted

Up to Day 29

ID	Title	Description
OG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Abnormal Urinalysis Parameters Following IM Administration of Cabotegravir

Urinalysis included assessment of pH, glucose, protein, blood and ketones by dipstick method. This analysis was not planned and data was not collected and not captured in the database.

Safety Population. This analysis was not planned and data was not collected and not captured in the database.

Posted

Up to Week 52

ID	Title	Description
OG000	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG00122 events15 affected17 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0011 events1 affected17 at risk
Injection site erythema	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected17 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected17 at risk
Gait disturbance	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Influenza like illness	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Injection site induration	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Injection site pruritus	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Injection site reaction	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Injection site swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Thirst	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected19 at risk EG0010 events0 affected17 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Oral herpes	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Depression	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected17 at risk
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected17 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Palpitations	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected17 at risk
Blood glucose increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected19 at risk EG0010 events0 affected17 at risk
Haemoglobin decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0012 events2 affected17 at risk
Lethargy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected19 at risk EG0010 events0 affected17 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Dysuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Pelvic floor muscle weakness	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk

ID	Term
D007239	Infections
D000163	Acquired Immunodeficiency Syndrome
D015658	HIV Infections

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cabotegravir Oral 30 mg	All participants received oral 30 mg dose of CAB once per day for 28 days in Period 1.	0	19	0	19	10	19
EG001	Cabotegravir IM 600 mg	All participants received single IM dose of 600 mg cabotegravir in Period 2.	0	17	2	17	17	17

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pupils unequal	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Aphasia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Migraine with aura	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Serotonin syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected19 at risk EG0011 events1 affected17 at risk