HIV Infections, Infection, Human Immunodeficiency Virus
Conditions
Keywords
Cabotegravir, Pharmacokinetic, Healthy Adult Volunteers, GSK1265744
Brief summary
Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical sites associated with sexual HIV transmission following the proposed 600 milligram (mg) intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1 transmission and supplement the data to support future PrEP clinical trial development. The primary objective is to determine the PK concentrations of CAB following LA administration in plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF) in healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations associated with sexual HIV-1 transmission: VT, CT, CVF, RT and RF. The study will consist of a screening period, a 28-day oral lead-in phase at a dose of 30 mg per day followed by a 14-42 day washout period, and a single dose of CAB LA 600 mg as an IM (intragluteal) injection with compartmental pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will return for safety assessments and plasma PK sampling at Week 24 and Week 36 post-injection and undergo a follow-up/withdrawal visit at Week 52 post-injection.
Interventions
DRUGCabotegravir tablet 30 mg once daily for 28 days.
GSK1265744B, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, Aquarius film-coating, white BP18237
DRUGCabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
Cabotegravir will be supplied as sterile suspension for injection 200 mg/mL vial. Each vial appears as sterile white to slightly colored suspension containing 200 mg/mL of CAB for administration by intramuscular (intragluteal) injection and will be administered as 1 × 3 mL Injections (3 mL \[600 mg\] total) IM given once on Day 1 of injection phase
Sponsors
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 1: Pre-dose and 4 hours; one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36 and 52 post-dose | 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. |
| Cabotegravir Concentration in Vaginal Tissue Following IM Administration (Female Participants) | One sample on Day 3 and Week 8 post-dose | 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. |
| Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervical tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. |
| Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervicovaginal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. |
| Cabotegravir Concentration in Rectal Tissue Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. |
| Cabotegravir Concentration in Rectal Fluid Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Maximum Observed Concentration (Cmax) of Cabotegravir in Blood Plasma Following IM Administration | Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose | Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Cmax of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervical tissue samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Cmax of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervicovaginal fluid samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Cmax of Cabotegravir in Rectal Tissue Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal tissue samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Cmax of Cabotegravir in Rectal Fluid Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal fluid samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| 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 | Day 1: Pre-dose, 4 hours, One sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose | Blood samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-last) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervical tissue samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-last) of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervicovaginal fluid samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-last) for Cabotegravir in Rectal Tissue Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal tissue samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-last) for Cabotegravir in Rectal Fluid Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal fluid samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-inf]) for Cabotegravir in Blood Plasma Following IM Administration | Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose | Blood samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-inf) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervical tissue samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-inf) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervicovaginal fluid samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-inf) for Cabotegravir in Rectal Tissue Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal tissue samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-inf) for Cabotegravir in Rectal Fluid Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal fluid samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Area Under the Concentration Time Curve From Time Zero to Week (WK) 4 (AUC[0-WK4]) for Cabotegravir in Blood Plasma Following IM Administration | Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8 and Week 4 post-dose | Blood samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK4) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | One sample on Days 3, 8 and Week 4 post-dose | Cervical tissue samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK4) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Days 3, 8 and Week 4 post-dose | Cervicovaginal fluid samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK4) for Cabotegravir in Rectal Tissue Following IM Administration | One sample on Days 3, 8 and Week 4 post-dose | Rectal tissue samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK4) for Cabotegravir in Rectal Fluid Following IM Administration | One sample on Days 3, 8 and Week 4 post-dose | Rectal fluid samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Area Under the Concentration Time Curve From Time Zero to Week 8 (AUC[0-WK8]) for Cabotegravir in Blood Plasma Following IM Administration | Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4 and 8 post-dose | Blood samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK8) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4 and 8 post-dose | Cervical tissue samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK8) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4 and 8 post-dose | Cervicovaginal fluid samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK8) for Cabotegravir in Rectal Tissue Following IM Administration | One sample on Days 3, 8, Weeks 4 and 8 post-dose | Rectal tissue samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK8) for Cabotegravir in Rectal Fluid Following IM Administration | One sample on Days 3, 8, Weeks 4 and 8 post-dose | Rectal fluid samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Area Under the Concentration Time Curve From Time Zero to Week 12 (AUC[0-WK12]) for Cabotegravir in Blood Plasma Following IM Administration | Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8 and 12 post-dose | Blood samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK12) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervical tissue samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK12) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervicovaginal fluid samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK12) for Cabotegravir in Rectal Tissue Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal tissue samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| AUC(0-WK12) for Cabotegravir in Rectal Fluid Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal fluid samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Apparent Terminal Phase Half-life (t1/2) of Cabotegravir in Blood Plasma Following IM Administration | Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose | Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| t1/2 of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervical tissue samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| t1/2 of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Cervicovaginal fluid samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| t1/2 of Cabotegravir in Rectal Tissue Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal tissue samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| t1/2 of Cabotegravir in Rectal Fluid Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | Rectal fluid samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods. |
| Ratio of AUC(0-last) in Cervical Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-last) in Rectal Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-inf) in Cervical Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-inf) in Rectal Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-Wk4) in Cervical Tissue to AUC(0-Wk4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8 and Week 4 post-dose | 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. |
| Ratio of AUC(0-Wk 4) in Rectal Tissue to AUC(0-Wk 4) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8 and Week 4 post-dose | 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. |
| Ratio of AUC(0-WK8) in Cervical Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4 and 8 post-dose | 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. |
| Ratio of AUC(0-WK8) in Rectal Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8, Weeks 4 and 8 post-dose | 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. |
| Ratio of AUC(0-WK12) in Cervical Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-WK12) in Rectal Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-last) in Cervicovaginal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration-female Participants | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-last) in Rectal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-inf) in Cervicovaginal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-inf) in Rectal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-WK4) in Cervicovaginal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8 and Week 4 post-dose | 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. |
| Ratio of AUC(0-WK4) in Rectal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8 and Week 4 post-dose | 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. |
| Ratio of AUC(0-WK8) in Cervicovaginal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4 and 8 post-dose | 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. |
| Ratio of AUC(0-WK8) in Rectal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8, Weeks 4 and 8 post-dose | 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. |
| Ratio of AUC(0-WK12) in Cervicovaginal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of AUC(0-WK12) in Rectal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration | One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Cabotegravir Concentration in Vaginal Tissue Following Oral Administration (Female Participants) | 24 hours post-dose on Day 28 | Vaginal tissue samples were collected to measure cabotegravir concentration in vaginal tissue following oral 30 mg dose at indicated time-points. |
| Cabotegravir Concentration in Cervical Tissue Following Oral Administration (Female Participants) | 24 hours post-dose on Day 28 | Cervical tissue samples were collected to measure cabotegravir concentration in cervical tissue following oral 30 mg dose at indicated time-points. |
| Cabotegravir Concentration in Cervicovaginal Fluid Following Oral Administration (Female Participants) | 24 hours post-dose on Day 28 | Cervicovaginal fluid samples were collected to measure cabotegravir concentration in cervicovaginal fluid following oral 30 mg dose at indicated time-points. |
| Cabotegravir Concentration in Rectal Tissue Following Oral Administration | 24 hours post-dose on Day 28 | Rectal tissue samples were collected to measure cabotegravir concentration in rectal tissue following oral 30 mg dose at indicated time-points. |
| Cabotegravir Concentration in Rectal Fluid Following Oral Administration | 24 hours post-dose on Day 28 | Rectal fluid samples were collected to measure cabotegravir concentration in rectal fluid following oral 30 mg dose at indicated time-points. |
| Cabotegravir Concentration in Blood Plasma Following Oral Administration | 24 hours post-dose on Day 28 | Blood samples were collected to measure cabotegravir concentration in blood plasma following oral 30 mg dose at indicated time-points. |
| Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Serious Adverse Events (SAE) Following Oral Administration of Cabotegravir | Up to Day 29 | 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. |
| Number of Participants With Any Non-SAE and SAE Following IM Administration of Cabotegravir | Up to Week 52 | 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. |
| Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Creatine Kinase at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in Creatine Kinase at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 8 and 12 | 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. |
| Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4 and 8 | 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. |
| Change From Baseline in Total Neutrophil Count at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29 | 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. |
| Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29 | 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. |
| Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29 | 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. |
| Change From Baseline in MCH at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29 | 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. |
| Change From Baseline in MCV at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29 | 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. |
| Change From Baseline in Hematocrit at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29 | 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. |
| Change From Baseline in RBC Count at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12 | 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. |
| Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | One sample on Day 3 and Week 8 post-dose | 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. |
| Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 | 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. |
| Change From Baseline in Pulse Rate at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 | 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. |
| Change From Baseline in Body Temperature at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 | 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. |
| Number of Participants With Abnormal Urinalysis Parameters Following Oral Administration of Cabotegravir | Up to Day 29 | 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. |
| Number of Participants With Abnormal Urinalysis Parameters Following IM Administration of Cabotegravir | Up to Week 52 | 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. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose) | Baseline (Day 1, Pre-dose), Days 14 and 29 | 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. |
| Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
| Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Day 3, 8, Weeks 4, 8 and 12 | 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. |
| Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | One sample on Day 3 and Week 8 post-dose | 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. |
| Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration | One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose | 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. |
Countries
United States
Participant flow
Recruitment details
This was a Phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir (CAB) long-acting (LA) in the blood plasma and anatomical tissues and secretions associated with sexual human immunodeficiency virus (HIV)-1 transmission. The study was conducted across two centers in the United States.
Pre-assignment details
A total of 29 participants were screened, of which 10 failed screening. A total of 19 participants were enrolled in the study and received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Treatment Period 1 (Up to Day 29) | Physician Decision | 1 |
| Treatment Period 2 (Up to 52 Weeks) | Withdrawal by Subject | 1 |
| Washout Period (Up to 42 Days) | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Cabotegravir Oral 30 mg Followed by Cabotegravir IM 600 mg |
|---|---|
| Age, Continuous | 33.3 Years STANDARD_DEVIATION 9.12 |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 12 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 10 / 19 | 17 / 17 |
| serious Total, serious adverse events | 0 / 19 | 2 / 17 |
Outcome results
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.
Time frame: Day 1: Pre-dose and 4 hours; one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36 and 52 post-dose
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 1: Pre-dose, n=15 | 0.0000 Micrograms per milliliter | — |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 1: 4 hours, n=15 | 0.2864 Micrograms per milliliter | Standard Deviation 0.10463 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 3, n=15 | 3.2748 Micrograms per milliliter | Standard Deviation 1.74419 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 5, n=15 | 5.1071 Micrograms per milliliter | Standard Deviation 3.0918 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 8, n=15 | 5.0433 Micrograms per milliliter | Standard Deviation 2.92704 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 4, n=15 | 2.5583 Micrograms per milliliter | Standard Deviation 1.00963 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 8, n=15 | 0.9683 Micrograms per milliliter | Standard Deviation 0.73601 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 12, n=15 | 0.3925 Micrograms per milliliter | Standard Deviation 0.40471 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 24, n=15 | 0.0550 Micrograms per milliliter | — |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 36, n=15 | 0.0213 Micrograms per milliliter | — |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 52, n=14 | 0.0089 Micrograms per milliliter | — |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants) | Day 8 | 0.9261 Micrograms per milliliter | Standard Deviation 0.85513 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants) | Day 3 | 0.8016 Micrograms per milliliter | Standard Deviation 0.70126 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants) | Week 4 | 0.4409 Micrograms per milliliter | Standard Deviation 0.29216 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants) | Week 8 | 0.1570 Micrograms per milliliter | Standard Deviation 0.14909 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants) | Week 12 | 0.0460 Micrograms per milliliter | — |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Day 3 | 0.6604 Micrograms per milliliter | Standard Deviation 0.91588 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Day 8 | 0.6175 Micrograms per milliliter | Standard Deviation 0.59792 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Week 4 | 0.3209 Micrograms per milliliter | Standard Deviation 0.37093 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Week 8 | 0.0905 Micrograms per milliliter | Standard Deviation 0.14821 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Week 12 | 0.0901 Micrograms per milliliter | Standard Deviation 0.18306 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Fluid Following IM Administration | Day 3 | 1.3868 Micrograms per milliliter | Standard Deviation 1.88097 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Fluid Following IM Administration | Day 8 | 3.2046 Micrograms per milliliter | Standard Deviation 2.68417 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Fluid Following IM Administration | Week 4 | 5.2674 Micrograms per milliliter | Standard Deviation 7.99949 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Fluid Following IM Administration | Week 8 | 0.3233 Micrograms per milliliter | Standard Deviation 0.22764 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Fluid Following IM Administration | Week 12 | 0.7901 Micrograms per milliliter | Standard Deviation 1.7543 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Tissue Following IM Administration | Day 8 | 0.5146 Micrograms per milliliter | Standard Deviation 0.26514 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Tissue Following IM Administration | Day 3 | 0.2824 Micrograms per milliliter | Standard Deviation 0.17814 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Tissue Following IM Administration | Week 4 | 0.2620 Micrograms per milliliter | Standard Deviation 0.10476 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Tissue Following IM Administration | Week 8 | 0.1037 Micrograms per milliliter | Standard Deviation 0.1005 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Tissue Following IM Administration | Week 12 | 0.0348 Micrograms per milliliter | — |
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.
Time frame: One sample on Day 3 and Week 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Vaginal Tissue Following IM Administration (Female Participants) | Day 3 | 0.5286 Micrograms per milliliter | Standard Deviation 0.48215 |
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Vaginal Tissue Following IM Administration (Female Participants) | Week 8 | 0.1809 Micrograms per milliliter | Standard Deviation 0.14606 |
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.
Time frame: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose
Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Apparent Terminal Phase Half-life (t1/2) of Cabotegravir in Blood Plasma Following IM Administration | 459.53 Hours | Geometric Coefficient of Variation 81.4 |
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.
Time frame: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose
Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-inf]) for Cabotegravir in Blood Plasma Following IM Administration | 4172.17 Hours*microgram per milliliter | Geometric Coefficient of Variation 23.9 |
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.
Time frame: Day 1: Pre-dose, 4 hours, One sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose
Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | 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 | 3992.25 Hours*microgram per milliliter | Geometric Coefficient of Variation 24.5 |
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.
Time frame: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Area Under the Concentration Time Curve From Time Zero to Week 12 (AUC[0-WK12]) for Cabotegravir in Blood Plasma Following IM Administration | 3639.01 Hours*microgram per milliliter | Geometric Coefficient of Variation 35.6 |
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.
Time frame: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4 and 8 post-dose
Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Area Under the Concentration Time Curve From Time Zero to Week 8 (AUC[0-WK8]) for Cabotegravir in Blood Plasma Following IM Administration | 3213.62 Hours*microgram per milliliter | Geometric Coefficient of Variation 40.1 |
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.
Time frame: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8 and Week 4 post-dose
Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Area Under the Concentration Time Curve From Time Zero to Week (WK) 4 (AUC[0-WK4]) for Cabotegravir in Blood Plasma Following IM Administration | 2141.91 Hours*microgram per milliliter | Geometric Coefficient of Variation 59.2 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-inf) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | 695.72 Hours*microgram per milliliter |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-inf) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | 399.07 Hours*microgram per milliliter | Geometric Coefficient of Variation 99.9 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-inf) for Cabotegravir in Rectal Fluid Following IM Administration | 850.05 Hours*microgram per milliliter | Geometric Coefficient of Variation 42.7 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-inf) for Cabotegravir in Rectal Tissue Following IM Administration | 291.98 Hours*microgram per milliliter | Geometric Coefficient of Variation 34.6 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-last) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | 522.73 Hours*microgram per milliliter | Geometric Coefficient of Variation 77 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-last) for Cabotegravir in Rectal Fluid Following IM Administration | 1841.23 Hours*microgram per milliliter | Geometric Coefficient of Variation 193.8 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-last) for Cabotegravir in Rectal Tissue Following IM Administration | 347.73 Hours*microgram per milliliter | Geometric Coefficient of Variation 35.5 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-last) of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | 324.33 Hours*microgram per milliliter | Geometric Coefficient of Variation 121.4 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK12) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | 349.98 Hours*microgram per milliliter | Geometric Coefficient of Variation 78.9 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK12) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | 380.92 Hours*microgram per milliliter | Geometric Coefficient of Variation 107.8 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK12) for Cabotegravir in Rectal Fluid Following IM Administration | 1345.13 Hours*microgram per milliliter | Geometric Coefficient of Variation 137.7 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK12) for Cabotegravir in Rectal Tissue Following IM Administration | 323.91 Hours*microgram per milliliter | Geometric Coefficient of Variation 54.8 |
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.
Time frame: One sample on Days 3, 8 and Week 4 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK4) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | 277.48 Hours*microgram per milliliter | Geometric Coefficient of Variation 103.6 |
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.
Time frame: One sample on Days 3, 8 and Week 4 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK4) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | 203.32 Hours*microgram per milliliter | Geometric Coefficient of Variation 125.5 |
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.
Time frame: One sample on Days 3, 8 and Week 4 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK4) for Cabotegravir in Rectal Fluid Following IM Administration | 1170.49 Hours*microgram per milliliter | Geometric Coefficient of Variation 192.1 |
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.
Time frame: One sample on Days 3, 8 and Week 4 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK4) for Cabotegravir in Rectal Tissue Following IM Administration | 206.28 Hours*microgram per milliliter | Geometric Coefficient of Variation 57.2 |
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.
Time frame: One sample on Days 3, 8, Weeks 4 and 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK8) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | 364.74 Hours*microgram per milliliter | Geometric Coefficient of Variation 85.2 |
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.
Time frame: One sample on Days 3, 8, Weeks 4 and 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK8) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | 281.60 Hours*microgram per milliliter | Geometric Coefficient of Variation 124.8 |
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.
Time frame: One sample on Days 3, 8, Weeks 4 and 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK8) for Cabotegravir in Rectal Fluid Following IM Administration | 1575.54 Hours*microgram per milliliter | Geometric Coefficient of Variation 202.9 |
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.
Time frame: One sample on Days 3, 8, Weeks 4 and 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | AUC(0-WK8) for Cabotegravir in Rectal Tissue Following IM Administration | 287.35 Hours*microgram per milliliter | Geometric Coefficient of Variation 38.7 |
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.
Time frame: 24 hours post-dose on Day 28
Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Blood Plasma Following Oral Administration | 5.7313 Micrograms per milliliter | Standard Deviation 2.08899 |
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.
Time frame: 24 hours post-dose on Day 28
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervical Tissue Following Oral Administration (Female Participants) | 1.1009 Micrograms per milliliter | Standard Deviation 0.53987 |
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.
Time frame: 24 hours post-dose on Day 28
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Cervicovaginal Fluid Following Oral Administration (Female Participants) | 0.8959 Micrograms per milliliter | Standard Deviation 0.95662 |
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.
Time frame: 24 hours post-dose on Day 28
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Fluid Following Oral Administration | 5.5457 Micrograms per milliliter | Standard Deviation 6.41639 |
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.
Time frame: 24 hours post-dose on Day 28
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Rectal Tissue Following Oral Administration | 0.6104 Micrograms per milliliter | Standard Deviation 0.24854 |
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.
Time frame: 24 hours post-dose on Day 28
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cabotegravir Concentration in Vaginal Tissue Following Oral Administration (Female Participants) | 0.7477 Micrograms per milliliter | Standard Deviation 0.50171 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose) | AST, Day 29 | 1.1 International units per Liter | Standard Deviation 6.14 |
| Cabotegravir IM 600 mg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose) | ALT, Day 29 | 3.5 International units per Liter | Standard Deviation 10.12 |
| Cabotegravir IM 600 mg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose) | ALP, Day 14 | -0.2 International units per Liter | Standard Deviation 6.44 |
| Cabotegravir IM 600 mg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose) | ALP, Day 29 | -0.4 International units per Liter | Standard Deviation 3.24 |
| Cabotegravir IM 600 mg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose) | AST, Day 14 | -0.3 International units per Liter | Standard Deviation 3.6 |
| Cabotegravir IM 600 mg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose) | ALT, Day 14 | 1.7 International units per Liter | Standard Deviation 8.98 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose) | Albumin, Week 4, n=17 | 0.3 Grams per liter | Standard Deviation 2.66 |
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose) | Albumin, Week 8, n=16 | 0.3 Grams per liter | Standard Deviation 2.41 |
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose) | Albumin, Week 12, n=16 | 0.6 Grams per liter | Standard Deviation 2.42 |
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose) | Total protein, Week 4, n=17 | 0.2 Grams per liter | Standard Deviation 3.23 |
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose) | Total protein, Week 8, n=15 | -0.1 Grams per liter | Standard Deviation 3.53 |
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose) | Total protein, Week 12, n=16 | 0.5 Grams per liter | Standard Deviation 4.31 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose) | Albumin, Day 14 | -0.6 Grams per liter | Standard Deviation 2.85 |
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose) | Albumin, Day 29 | -0.3 Grams per liter | Standard Deviation 1.53 |
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose) | Total protein, Day 14 | -1.7 Grams per liter | Standard Deviation 3.48 |
| Cabotegravir IM 600 mg | Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose) | Total protein, Day 29 | -1.4 Grams per liter | Standard Deviation 2.23 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | ALT, Week 4, n=17 | -0.2 International units per Liter | Standard Deviation 4.05 |
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | ALT, Week 8, n=16 | -0.8 International units per Liter | Standard Deviation 5.33 |
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | ALT, Week 12, n=16 | -1.4 International units per Liter | Standard Deviation 3.81 |
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | ALP, Week 4, n=15 | 2.1 International units per Liter | Standard Deviation 6.39 |
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | ALP, Week 8, n=16 | 0.6 International units per Liter | Standard Deviation 8.43 |
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | ALP, Week 12, n=16 | 1.3 International units per Liter | Standard Deviation 6.57 |
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | AST, Week 4, n=17 | 0.1 International units per Liter | Standard Deviation 2.87 |
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | AST, Week 8, n=16 | 0.1 International units per Liter | Standard Deviation 3.76 |
| Cabotegravir IM 600 mg | Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose) | AST, Week 12, n=16 | -0.1 International units per Liter | Standard Deviation 3.5 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4 and 8
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Basophils, Week 8, n=1 | 0.00 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Eosinophils, Week 4, n=3 | 0.000 Giga cells per Liter | Standard Deviation 0 |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Eosinophils, Week 8, n=1 | 0.000 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Lymphocytes, Week 4, n=3 | 0.073 Giga cells per Liter | Standard Deviation 0.3607 |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Lymphocytes, Week 8, n=1 | -0.300 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Monocytes, Week 4, n=3 | -0.040 Giga cells per Liter | Standard Deviation 0.2425 |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Monocytes, Week 8, n=1 | 0.000 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose) | Basophils, Week 4, n=3 | 0.03 Giga cells per Liter | Standard Deviation 0.058 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Basophils, Day 14, n=1 | -0.30 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Eosinophils, Day 29, n=2 | 0.100 Giga cells per Liter | Standard Deviation 0.1414 |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Lymphocytes, Day 14, n=1 | 0.500 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Lymphocytes, Day 29, n=2 | 0.400 Giga cells per Liter | Standard Deviation 0.1414 |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Monocytes, Day 14, n=1 | 0.000 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Monocytes, Day 29, n=2 | -0.100 Giga cells per Liter | Standard Deviation 0 |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Basophils, Day 29, n=2 | -0.05 Giga cells per Liter | Standard Deviation 0.212 |
| Cabotegravir IM 600 mg | Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose) | Eosinophils, Day 14, n=1 | 0.000 Giga cells per Liter | — |
Secondary
Change From Baseline in Body Temperature at Indicated Time Points (IM 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.
Time frame: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Week 52, n=15 | 0.1 Degrees Celsius | Standard Deviation 0.61 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Day 3, n=17 | -0.0 Degrees Celsius | Standard Deviation 0.36 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Day 5, n=17 | 0.2 Degrees Celsius | Standard Deviation 0.52 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Day 8, n=17 | 0.0 Degrees Celsius | Standard Deviation 0.37 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Week 4, n=17 | -0.1 Degrees Celsius | Standard Deviation 0.31 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Week 8, n=16 | -0.0 Degrees Celsius | Standard Deviation 0.47 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Week 12, n=16 | 0.2 Degrees Celsius | Standard Deviation 0.37 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Week 24, n=16 | -0.0 Degrees Celsius | Standard Deviation 0.39 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (IM Dose) | Week 36, n=16 | -0.1 Degrees Celsius | Standard Deviation 0.58 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (Oral Dose) | Day 14 | -0.2 Degrees Celsius | Standard Deviation 0.54 |
| Cabotegravir IM 600 mg | Change From Baseline in Body Temperature at Indicated Time Points (Oral Dose) | Day 29 | -0.1 Degrees Celsius | Standard Deviation 0.46 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | UEC, Week 12, n=16 | -0.3570 Millimoles per Liter | Standard Deviation 1.18762 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Calcium, Week 4, n=17 | -0.002935 Millimoles per Liter | Standard Deviation 0.0763335 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Calcium, Week 8, n=15 | -0.003327 Millimoles per Liter | Standard Deviation 0.0610177 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Calcium, Week 12, n=16 | -0.001559 Millimoles per Liter | Standard Deviation 0.0666177 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Glucose, Week 4, n=17 | -0.111020 Millimoles per Liter | Standard Deviation 0.646757 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Glucose, Week 8, n=16 | -0.003469 Millimoles per Liter | Standard Deviation 0.8073398 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Glucose, Week 12, n=16 | -0.149183 Millimoles per Liter | Standard Deviation 0.6402427 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Potassium, Week 4, n=17 | -0.08 Millimoles per Liter | Standard Deviation 0.26 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Potassium, Week 8, n=16 | -0.07 Millimoles per Liter | Standard Deviation 0.236 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Potassium, Week 12, n=16 | 0.01 Millimoles per Liter | Standard Deviation 0.379 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Sodium, Week 4, n=17 | -0.4 Millimoles per Liter | Standard Deviation 2.06 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Sodium, Week 8, n=16 | 0.1 Millimoles per Liter | Standard Deviation 1.77 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | Sodium, Week 12, n=16 | -0.6 Millimoles per Liter | Standard Deviation 1.79 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | UEC, Week 4, n=17 | -0.5250 Millimoles per Liter | Standard Deviation 1.01068 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose) | UEC, Week 8, n=16 | -0.6694 Millimoles per Liter | Standard Deviation 1.20801 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Glucose, Day 14 | 0.391654 Millimoles per Liter | Standard Deviation 0.6929202 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Glucose, Day 29 | 0.672288 Millimoles per Liter | Standard Deviation 1.0302415 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Potassium, Day 14 | -0.05 Millimoles per Liter | Standard Deviation 0.296 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | UEC, Day 14 | -0.2975 Millimoles per Liter | Standard Deviation 0.97384 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | UEC, Day 29 | -0.2578 Millimoles per Liter | Standard Deviation 1.14741 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Calcium, Day 14 | -0.027722 Millimoles per Liter | Standard Deviation 0.0905221 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Calcium, Day 29 | -0.033267 Millimoles per Liter | Standard Deviation 0.077494 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Potassium, Day 29 | -0.04 Millimoles per Liter | Standard Deviation 0.241 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Sodium, Day 14 | -0.9 Millimoles per Liter | Standard Deviation 1.53 |
| Cabotegravir IM 600 mg | Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose) | Sodium, Day 29 | -0.3 Millimoles per Liter | Standard Deviation 2.43 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Creatine Kinase at Indicated Time Points (IM Dose) | Week 8 | 19.6 International units per Liter | Standard Deviation 67.42 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatine Kinase at Indicated Time Points (IM Dose) | Week 12 | 22.2 International units per Liter | Standard Deviation 92.09 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Creatine Kinase at Indicated Time Points (Oral Dose) | Day 14 | -19.9 International units per Liter | Standard Deviation 27.23 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatine Kinase at Indicated Time Points (Oral Dose) | Day 29 | -8.9 International units per Liter | Standard Deviation 46.56 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Total bilirubin, Week 12, n=14 | 1.099 Micromoles per liter | Standard Deviation 4.5789 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Creatinine, Week 4, n=17 | -3.640 Micromoles per liter | Standard Deviation 8.3037 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Creatinine, Week 8, n=16 | -5.525 Micromoles per liter | Standard Deviation 5.4732 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Creatinine, Week 12, n=16 | -3.315 Micromoles per liter | Standard Deviation 8.4637 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Direct bilirubin, Week 4, n=10 | -0.171 Micromoles per liter | Standard Deviation 0.5407 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Direct bilirubin, Week 8, n=10 | 0.171 Micromoles per liter | Standard Deviation 1.2617 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Direct bilirubin, Week 12, n=9 | 0.190 Micromoles per liter | Standard Deviation 1.3368 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Total bilirubin, Week 4, n=16 | 0.641 Micromoles per liter | Standard Deviation 3.1142 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose) | Total bilirubin, Week 8, n=15 | 0.114 Micromoles per liter | Standard Deviation 4.2118 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose) | Creatinine, Day 14, n=18 | 0.491 Micromoles per liter | Standard Deviation 5.65 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose) | Creatinine, Day 29, n=18 | -0.491 Micromoles per liter | Standard Deviation 7.0929 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose) | Direct bilirubin, Day 14, n=11 | -0.311 Micromoles per liter | Standard Deviation 0.6917 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose) | Direct bilirubin, Day 29, n=12 | 0.428 Micromoles per liter | Standard Deviation 0.7734 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose) | Total bilirubin, Day 14, n=16 | -1.282 Micromoles per liter | Standard Deviation 1.9245 |
| Cabotegravir IM 600 mg | Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose) | Total bilirubin, Day 29, n=16 | 0.000 Micromoles per liter | Standard Deviation 2.7217 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Hematocrit at Indicated Time Points (IM Dose) | Week 4, n=17 | -0.0034 Proportion of red blood cells in blood | Standard Deviation 0.01703 |
| Cabotegravir IM 600 mg | Change From Baseline in Hematocrit at Indicated Time Points (IM Dose) | Week 8, n=16 | 0.0030 Proportion of red blood cells in blood | Standard Deviation 0.02145 |
| Cabotegravir IM 600 mg | Change From Baseline in Hematocrit at Indicated Time Points (IM Dose) | Week 12, n=16 | 0.0025 Proportion of red blood cells in blood | Standard Deviation 0.02196 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose) | Day 1 (post-dose), n=1 | -0.0060 Proportion of red blood cells in blood | — |
| Cabotegravir IM 600 mg | Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose) | Day 14, n=17 | -0.0135 Proportion of red blood cells in blood | Standard Deviation 0.02456 |
| Cabotegravir IM 600 mg | Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose) | Day 29, n=18 | -0.0122 Proportion of red blood cells in blood | Standard Deviation 0.02084 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose) | Hemoglobin, Week 4, n=17 | -0.8 Grams per Liter | Standard Deviation 5.25 |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose) | Hemoglobin, Week 8, n=16 | 0.8 Grams per Liter | Standard Deviation 6.56 |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose) | Hemoglobin, Week 12, n=16 | 1.4 Grams per Liter | Standard Deviation 7.31 |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose) | MCHC, Week 4, n=17 | 0.9 Grams per Liter | Standard Deviation 7.39 |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose) | MCHC, Week 8, n=16 | -0.8 Grams per Liter | Standard Deviation 6.33 |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose) | MCHC, Week 12, n=16 | 1.8 Grams per Liter | Standard Deviation 6.84 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose) | Hemoglobin, Day 1 (post-dose), n=1 | -6.0 Grams per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose) | Hemoglobin, Day 14, n=17 | -5.1 Grams per Liter | Standard Deviation 7.6 |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose) | Hemoglobin, Day 29, n=18 | -3.6 Grams per Liter | Standard Deviation 6.93 |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose) | MCHC, Day 1 (post-dose), n=1 | -8.0 Grams per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose) | MCHC, Day 14, n=17 | -1.2 Grams per Liter | Standard Deviation 6.93 |
| Cabotegravir IM 600 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose) | MCHC, Day 29, n=18 | 1.3 Grams per Liter | Standard Deviation 7.81 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in MCH at Indicated Time Points (IM Dose) | Week 4, n=17 | -0.15 Picograms | Standard Deviation 0.292 |
| Cabotegravir IM 600 mg | Change From Baseline in MCH at Indicated Time Points (IM Dose) | Week 8, n=16 | -0.39 Picograms | Standard Deviation 0.584 |
| Cabotegravir IM 600 mg | Change From Baseline in MCH at Indicated Time Points (IM Dose) | Week 12, n=16 | -0.36 Picograms | Standard Deviation 0.778 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in MCV at Indicated Time Points (IM Dose) | Week 4, n=17 | -0.67 Femtoliters | Standard Deviation 1.771 |
| Cabotegravir IM 600 mg | Change From Baseline in MCV at Indicated Time Points (IM Dose) | Week 8, n=16 | -1.03 Femtoliters | Standard Deviation 1.799 |
| Cabotegravir IM 600 mg | Change From Baseline in MCV at Indicated Time Points (IM Dose) | Week 12, n=16 | -1.63 Femtoliters | Standard Deviation 1.861 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose) | Day 1 (post-dose), n=1 | -0.90 Picograms | — |
| Cabotegravir IM 600 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose) | Day 14, n=17 | -0.22 Picograms | Standard Deviation 0.629 |
| Cabotegravir IM 600 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose) | Day 29, n=18 | -0.01 Picograms | Standard Deviation 0.567 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose) | Day 1 (post-dose), n=1 | -0.20 Femtoliters | — |
| Cabotegravir IM 600 mg | Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose) | Day 14, n=17 | -0.40 Femtoliters | Standard Deviation 1.052 |
| Cabotegravir IM 600 mg | Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose) | Day 29, n=18 | -0.34 Femtoliters | Standard Deviation 1.303 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose) | Platelets, Week 4, n=17 | 11.7 Giga cells per Liter | Standard Deviation 21 |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose) | Platelets, Week 8, n=16 | 12.0 Giga cells per Liter | Standard Deviation 25.72 |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose) | Platelets, Week 12, n=16 | 7.3 Giga cells per Liter | Standard Deviation 18.34 |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose) | WBCs, Week 4, n=17 | -0.053 Giga cells per Liter | Standard Deviation 1.1486 |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose) | WBCs, Week 8, n=16 | -0.085 Giga cells per Liter | Standard Deviation 0.7777 |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose) | WBCs, Week 12, n=16 | -0.159 Giga cells per Liter | Standard Deviation 0.9395 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose) | Platelets, Day 1 (post-dose), n=1 | 39.0 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose) | Platelets, Day 14, n=17 | -6.6 Giga cells per Liter | Standard Deviation 30.83 |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose) | Platelets, Day 29, n=18 | 8.7 Giga cells per Liter | Standard Deviation 29.14 |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose) | WBCs, Day 1, n=1 | 2.100 Giga cells per Liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose) | WBCs, Day 14, n=17 | -0.056 Giga cells per Liter | Standard Deviation 0.8815 |
| Cabotegravir IM 600 mg | Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose) | WBCs, Day 29, n=18 | -0.263 Giga cells per Liter | Standard Deviation 1.1894 |
Secondary
Change From Baseline in Pulse Rate at Indicated Time Points (IM 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.
Time frame: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Day 3, n=17 | -0.9 Beats per minute | Standard Deviation 10.51 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Day 5, n=17 | 6.2 Beats per minute | Standard Deviation 7.66 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Day 8, n=17 | 1.6 Beats per minute | Standard Deviation 9.06 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Week 4, n=17 | -0.6 Beats per minute | Standard Deviation 7.4 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Week 8, n=16 | -0.9 Beats per minute | Standard Deviation 7.85 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Week 12, n=16 | 1.3 Beats per minute | Standard Deviation 11.8 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Week 24, n=16 | 1.1 Beats per minute | Standard Deviation 6.87 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Week 36, n=16 | 2.6 Beats per minute | Standard Deviation 11.07 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose) | Week 52, n=15 | 1.9 Beats per minute | Standard Deviation 10.59 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (Oral Dose) | Day 29 | 2.4 Beats per minute | Standard Deviation 8.23 |
| Cabotegravir IM 600 mg | Change From Baseline in Pulse Rate at Indicated Time Points (Oral Dose) | Day 14 | -1.0 Beats per minute | Standard Deviation 5.72 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in RBC Count at Indicated Time Points (IM Dose) | Week 4, n=17 | -0.004 Trillion cells per liter | Standard Deviation 0.1718 |
| Cabotegravir IM 600 mg | Change From Baseline in RBC Count at Indicated Time Points (IM Dose) | Week 8, n=16 | 0.087 Trillion cells per liter | Standard Deviation 0.2129 |
| Cabotegravir IM 600 mg | Change From Baseline in RBC Count at Indicated Time Points (IM Dose) | Week 12, n=16 | 0.117 Trillion cells per liter | Standard Deviation 0.2266 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose) | Day 1 (post-dose), n=1 | -0.050 Trillion cells per liter | — |
| Cabotegravir IM 600 mg | Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose) | Day 14, n=17 | -0.126 Trillion cells per liter | Standard Deviation 0.2813 |
| Cabotegravir IM 600 mg | Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose) | Day 29, n=18 | -0.114 Trillion cells per liter | Standard Deviation 0.236 |
Secondary
Change From Baseline in SBP and DBP at Indicated Time Points (IM 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.
Time frame: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Day 3, n=17 | 0.5 Millimeters of mercury | Standard Deviation 4.11 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Day 3, n=17 | 0.1 Millimeters of mercury | Standard Deviation 10.15 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Day 5, n=17 | -1.5 Millimeters of mercury | Standard Deviation 10.44 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Day 8, n=17 | 3.2 Millimeters of mercury | Standard Deviation 13.18 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Week 4, n=17 | 1.8 Millimeters of mercury | Standard Deviation 12.11 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Week 8, n=16 | 0.9 Millimeters of mercury | Standard Deviation 9.23 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Week 12, n=16 | -1.1 Millimeters of mercury | Standard Deviation 11.69 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Week 24, n=16 | 2.0 Millimeters of mercury | Standard Deviation 12.88 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Week 36, n=16 | 1.7 Millimeters of mercury | Standard Deviation 11.44 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | SBP, Week 52, n=15 | 0.7 Millimeters of mercury | Standard Deviation 13.08 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Day 5, n=17 | -0.7 Millimeters of mercury | Standard Deviation 4.69 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Day 8, n=17 | 0.6 Millimeters of mercury | Standard Deviation 5.36 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Week 4, n=17 | -0.4 Millimeters of mercury | Standard Deviation 5.2 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Week 8, n=16 | 3.3 Millimeters of mercury | Standard Deviation 5.65 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Week 12, n=16 | 0.2 Millimeters of mercury | Standard Deviation 4.46 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Week 24, n=16 | 1.0 Millimeters of mercury | Standard Deviation 4.98 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Week 36, n=16 | 2.3 Millimeters of mercury | Standard Deviation 5.47 |
| Cabotegravir IM 600 mg | Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose) | DBP, Week 52, n=15 | 0.1 Millimeters of mercury | Standard Deviation 9.23 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose) | SBP, Day 14 | -1.3 Millimeters of mercury | Standard Deviation 8.55 |
| Cabotegravir IM 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose) | SBP, Day 29 | -1.0 Millimeters of mercury | Standard Deviation 8.64 |
| Cabotegravir IM 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose) | DBP, Day 14 | -0.9 Millimeters of mercury | Standard Deviation 7.57 |
| Cabotegravir IM 600 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose) | DBP, Day 29 | 0.5 Millimeters of mercury | Standard Deviation 5.96 |
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.
Time frame: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose) | Week 4, n=11 | 0.539 Giga cells per Liter | Standard Deviation 0.9379 |
| Cabotegravir IM 600 mg | Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose) | Week 8, n=8 | 0.010 Giga cells per Liter | Standard Deviation 0.8206 |
| Cabotegravir IM 600 mg | Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose) | Week 12, n=7 | -0.076 Giga cells per Liter | Standard Deviation 0.7115 |
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.
Time frame: Baseline (Day 1, Pre-dose), Days 14 and 29
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Change From Baseline in Total Neutrophil Count at Indicated Time Points (Oral Dose) | Day 14, n=9 | -0.353 Giga cells per Liter | Standard Deviation 0.6194 |
| Cabotegravir IM 600 mg | Change From Baseline in Total Neutrophil Count at Indicated Time Points (Oral Dose) | Day 29, n=11 | -0.565 Giga cells per Liter | Standard Deviation 1.1071 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cmax of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | 0.81 Micrograms per milliliter | Geometric Coefficient of Variation 105 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cmax of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | 0.55 Micrograms per milliliter | Geometric Coefficient of Variation 118.3 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cmax of Cabotegravir in Rectal Fluid Following IM Administration | 3.27 Micrograms per milliliter | Geometric Coefficient of Variation 171.9 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Cmax of Cabotegravir in Rectal Tissue Following IM Administration | 0.50 Micrograms per milliliter | Geometric Coefficient of Variation 47 |
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.
Time frame: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose
Population: Evaluable PK Plasma Parameter Summary Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Maximum Observed Concentration (Cmax) of Cabotegravir in Blood Plasma Following IM Administration | 5.04 Micrograms per milliliter | Geometric Coefficient of Variation 62 |
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.
Time frame: Up to Week 52
Population: Safety Population. This analysis was not planned and data was not collected and not captured in the database.
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.
Time frame: Up to Day 29
Population: Safety Population. This analysis was not planned and data was not collected and not captured in the database.
Secondary
Number of Participants With Any Non-SAE and SAE Following IM 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.
Time frame: Up to Week 52
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cabotegravir IM 600 mg | Number of Participants With Any Non-SAE and SAE Following IM Administration of Cabotegravir | Any Non-SAE | 17 Participants |
| Cabotegravir IM 600 mg | Number of Participants With Any Non-SAE and SAE Following IM Administration of Cabotegravir | Any SAE | 2 Participants |
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.
Time frame: Up to Day 29
Population: Safety Population comprised of all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cabotegravir IM 600 mg | Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Serious Adverse Events (SAE) Following Oral Administration of Cabotegravir | Any Non-SAE | 10 Participants |
| Cabotegravir IM 600 mg | Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Serious Adverse Events (SAE) Following Oral Administration of Cabotegravir | Any SAE | 0 Participants |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-inf) in Cervical Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.1943 Ratio |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-inf) in Cervicovaginal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.0857 Ratio | Geometric Coefficient of Variation 99.1 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-inf) in Rectal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration | 0.1949 Ratio | Geometric Coefficient of Variation 80.06 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-inf) in Rectal Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration | 0.0766 Ratio | Geometric Coefficient of Variation 42.26 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-last) in Cervical Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.1215 Ratio | Geometric Coefficient of Variation 64.86 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-last) in Cervicovaginal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration-female Participants | 0.0754 Ratio | Geometric Coefficient of Variation 99.37 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-last) in Rectal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration | 0.4445 Ratio | Geometric Coefficient of Variation 204.26 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-last) in Rectal Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration | 0.0849 Ratio | Geometric Coefficient of Variation 21.13 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK12) in Cervical Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.1230 Ratio | Geometric Coefficient of Variation 48.22 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK12) in Cervicovaginal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.0867 Ratio | Geometric Coefficient of Variation 99.56 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK12) in Rectal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration | 0.3863 Ratio | Geometric Coefficient of Variation 154.56 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK12) in Rectal Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration | 0.1089 Ratio | Geometric Coefficient of Variation 13.5 |
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.
Time frame: One sample on Days 3, 8 and Week 4 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-Wk4) in Cervical Tissue to AUC(0-Wk4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.1553 Ratio | Geometric Coefficient of Variation 50.33 |
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.
Time frame: One sample on Days 3, 8 and Week 4 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK4) in Cervicovaginal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.1032 Ratio | Geometric Coefficient of Variation 119.71 |
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.
Time frame: One sample on Days 3, 8 and Week 4 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK4) in Rectal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration | 0.5452 Ratio | Geometric Coefficient of Variation 223.58 |
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.
Time frame: One sample on Days 3, 8 and Week 4 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-Wk 4) in Rectal Tissue to AUC(0-Wk 4) in Blood Plasma for Cabotegravir Following IM Administration | 0.1000 Ratio | Geometric Coefficient of Variation 19.3 |
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.
Time frame: One sample on Days 3, 8, Weeks 4 and 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK8) in Cervical Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.1492 Ratio | Geometric Coefficient of Variation 52.3 |
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.
Time frame: One sample on Days 3, 8, Weeks 4 and 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK8) in Cervicovaginal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants) | 0.0925 Ratio | Geometric Coefficient of Variation 124.99 |
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.
Time frame: One sample on Days 3, 8, Weeks 4 and 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK8) in Rectal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration | 0.4845 Ratio | Geometric Coefficient of Variation 212.2 |
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.
Time frame: One sample on Days 3, 8, Weeks 4 and 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of AUC(0-WK8) in Rectal Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration | 0.1062 Ratio | Geometric Coefficient of Variation 17.46 |
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.
Time frame: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Day 3 | 0.203 Ratio | Geometric Coefficient of Variation 36.14 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Day 8 | 0.174 Ratio | Geometric Coefficient of Variation 44.85 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Week 4 | 0.139 Ratio | Geometric Coefficient of Variation 99.93 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Week 8 | 0.139 Ratio | Geometric Coefficient of Variation 59.16 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Week 12 | 0.101 Ratio | Geometric Coefficient of Variation 45.1 |
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.
Time frame: One sample on Day 3, 8, Weeks 4, 8 and 12
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Day 3 | 1.738 Ratio | Geometric Coefficient of Variation 118.75 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Day 8 | 1.405 Ratio | Geometric Coefficient of Variation 81.1 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Week 4 | 1.883 Ratio | Geometric Coefficient of Variation 172.44 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Week 8 | 2.785 Ratio | Geometric Coefficient of Variation 110.92 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Week 12 | 1.195 Ratio | Geometric Coefficient of Variation 105.01 |
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.
Time frame: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Day 8 | 0.124 Ratio | Geometric Coefficient of Variation 73.53 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Week 4 | 0.073 Ratio | Geometric Coefficient of Variation 277.59 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Week 8 | 0.057 Ratio | Geometric Coefficient of Variation 101.03 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Week 12 | 0.082 Ratio | Geometric Coefficient of Variation 112.91 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Day 3 | 0.116 Ratio | Geometric Coefficient of Variation 174.76 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 3 | 0.286 Ratio | Geometric Coefficient of Variation 157.6 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 8 | 0.581 Ratio | Geometric Coefficient of Variation 140.37 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 4 | 0.460 Ratio | Geometric Coefficient of Variation 923.37 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 8 | 0.302 Ratio | Geometric Coefficient of Variation 140.54 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 12 | 0.514 Ratio | Geometric Coefficient of Variation 185.97 |
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.
Time frame: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 3 | 0.078 Ratio | Geometric Coefficient of Variation 43.13 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration | Day 8 | 0.105 Ratio | Geometric Coefficient of Variation 22.92 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 4 | 0.104 Ratio | Geometric Coefficient of Variation 18.79 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 8 | 0.096 Ratio | Geometric Coefficient of Variation 27.81 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration | Week 12 | 0.091 Ratio | Geometric Coefficient of Variation 38.62 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration | Day 3, n=11 | 0.271 Ratio | Geometric Coefficient of Variation 150.25 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration | Day 8, n=12 | 0.185 Ratio | Geometric Coefficient of Variation 140.92 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration | Week 4, n=12 | 0.230 Ratio | Geometric Coefficient of Variation 1082.13 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration | Week 8, n=12 | 0.366 Ratio | Geometric Coefficient of Variation 133.2 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration | Week 12, n=12 | 0.093 Ratio | Geometric Coefficient of Variation 294.16 |
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.
Time frame: One sample on Day 3 and Week 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Day 3 | 0.128 Ratio | Geometric Coefficient of Variation 43.38 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants) | Week 8 | 0.199 Ratio | Geometric Coefficient of Variation 32.66 |
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.
Time frame: One sample on Day 3 and Week 8 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Day 3 | 1.095 Ratio | Geometric Coefficient of Variation 233.2 |
| Cabotegravir IM 600 mg | Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants) | Week 8 | 3.613 Ratio | Geometric Coefficient of Variation 115.25 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cabotegravir IM 600 mg | t1/2 of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants) | 363.41 Hours |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | t1/2 of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants) | 355.83 Hours | Geometric Coefficient of Variation 79.4 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | t1/2 of Cabotegravir in Rectal Fluid Following IM Administration | 306.58 Hours | Geometric Coefficient of Variation 3.5 |
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.
Time frame: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose
Population: Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM). Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cabotegravir IM 600 mg | t1/2 of Cabotegravir in Rectal Tissue Following IM Administration | 567.48 Hours | Geometric Coefficient of Variation 23.3 |