Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants

A Phase 1, Two-part, Double-blind, Active-control, Randomized Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Repeat-Dose Cabotegravir (CAB 400 mg/mL Formulation) Long-Acting Injection Following Subcutaneous or Intramuscular Administration in Healthy Adult Participants

This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL; Drug: Cabotegravir 200 mg/mL; Drug: Topical Non-steroidal anti-inflammatory drug (NSAID); Drug: Topical steroid; Drug: Topical NSAID placebo; Drug: Topical steroid placebo; Drug: Recombinant human hyaluronidase PH20 (rHuPH20)

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1010
    • GSK Investigational Site
• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • GSK Investigational Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78744
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Signs and symptoms which in the opinion of the investigator are suggestive of Coronavirus disease 2019 (COVID-19) (that is [i.e.] fever, cough etc) within 14 days of inpatient admission.
• Contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission.
• History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
• Abnormal blood pressure as determined by the investigator.
• Alanine transaminase (ALT) more than (>)1.5 times upper limit of normal (ULN).
• Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Corrected QT interval (QTc) >450 milliseconds (msec).
• A known hypersensitivity to hyaluronidases (Cohort 4h only).
• The participant has an underlying skin disease or disorder (infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that would interfere with assessment of injection sites.
• Current or anticipated need for chronic anti-coagulation with the exception of the use of low dose acetylsalicylic acid (less than or equal to [<=]325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.
• Participants considered to have insufficient musculature to allow safe administration of CAB 400 mg/mL (gluteus medius or vastus lateralis).
• History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.
• History of or on-going high-risk behaviors that may put the participant at increased risk for Human Immunodeficiency Virus (HIV) acquisition in the opinion of the investigator. This includes participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.
• Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
• The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
• A positive pre-study drug/alcohol screen.

• Exclusion criteria for screening electrocardiogram (ECG):

  1. Heart rate: For Males <45 or >100 beats per minute (bpm), for females <50 or >100 bpm.
  2. PR Interval: For males and females <120 or >220 msec.
  3. QRS duration: For males and females <70 or >120 msec.
  4. QT duration corrected for heart rate by Fridericia's formula (QTcF) interval: For males and females >450 msec.
• Evidence of previous myocardial infarction.
• Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular [AV] block [2nd degree or higher], Wolff-Parkinson-White [WPW] syndrome).
• Sinus Pauses >3 seconds.
• Any significant arrhythmia which, in the opinion of the Investigator or GlaxoSmithKline (GSK)/ViiV Medical monitor, will interfere with the safety for the individual participant.
• Non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
• Positive HIV antibody/antigen test. Participants will be advised regarding safer sex. In the event a participant acquires HIV during the course of the study they will be required to withdraw from the study and will be referred urgently to an HIV treatment center for further management.
• Regular use of known drugs of abuse.
• Regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
• Participants with a history of intolerance to or with contraindications to the use of topical non-steroidal anti-inflammatory drugs (NSAIDs) or topical steroids will be excluded from participation in Cohort 4b.
• Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of >14 units for males or >7 units for females.
• Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening.
• The participant has a tattoo or other dermatological condition overlying the location of injection or a prior history of silicone implants (gluteal) which may interfere with interpretation of injection site reactions or administration of CAB LA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Cabotegravir (CAB) 30; Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.
Experimental: Part 1: Cohort 1 (C1) CAB 400; Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 400 mg/mL; CAB 400 mg/mL administered intramascularly or subcutaneously.
Active Comparator: Part 1: Cohort 1 (C1) CAB200; Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 200 mg/mL; CAB 200 mg/mL administered intramascularly or subcutaneously.
Experimental: Part 1: Cohort 2 (C2) CAB400; Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 400 mg/mL; CAB 400 mg/mL administered intramascularly or subcutaneously.
Active Comparator: Part 1: Cohort 2 (C2) CAB200; Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 300 mg and Injection 2: 200 mg respectively) subcutaneously in the abdomen, 4 weeks apart, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 200 mg/mL; CAB 200 mg/mL administered intramascularly or subcutaneously.
Experimental: Part 1: Cohort 3 (C3) CAB400; Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 400 mg/mL; CAB 400 mg/mL administered intramascularly or subcutaneously.
Active Comparator: Part 1: Cohort 3 (C3) CAB200; Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 200 mg/mL; CAB 200 mg/mL administered intramascularly or subcutaneously.
Experimental: Part 1: Cohort 4 (C4) CAB400; Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB400 mg/mL (Injection 1: 400 mg and Injection 2: 200 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 400 mg/mL; CAB 400 mg/mL administered intramascularly or subcutaneously.
Active Comparator: Part 1: Cohort 4 (C4) CAB200; Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 400 mg and Injection 2: 100 mg respectively) at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, with the first injection in the gluteus medius intramuscularly and the second subcutaneously.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 200 mg/mL; CAB 200 mg/mL administered intramascularly or subcutaneously.
Experimental: Part 1: Cohort 4b Group 1 (C4b G1); Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase, The participants received a topical non-steroidal anti-inflammatory drug (NSAID) and topical steroid placebo with Injection 1, a topical steroid and NSAID placebo with Injection 2.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 400 mg/mL; CAB 400 mg/mL administered intramascularly or subcutaneously.; Drug: Topical Non-steroidal anti-inflammatory drug (NSAID); NSAID applied topically.; Drug: Topical steroid; Steroid medication applied topically.; Drug: Topical NSAID placebo; Placebo for NSAID applied topically.; Drug: Topical steroid placebo; Placebo for steroid applied topically.
Experimental: Part 1: Cohort 4b Group 2 (C4b G2); Following receipt of oral CAB 30 in the OLI phase, all participants received two injections of 300 mg of CAB 400 mg/mL subcutaneously 4 weeks apart. The participants received a topical steroid and NSAID placebo with injection 1, NSAID and topical steroid placebo with injection 2.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 400 mg/mL; CAB 400 mg/mL administered intramascularly or subcutaneously.; Drug: Topical Non-steroidal anti-inflammatory drug (NSAID); NSAID applied topically.; Drug: Topical steroid; Steroid medication applied topically.; Drug: Topical NSAID placebo; Placebo for NSAID applied topically.; Drug: Topical steroid placebo; Placebo for steroid applied topically.
Experimental: Part 1: Cohort 4h (C4h) CAB400 + rHuPH20; Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 400 mg/mL along with 5000 units (U) of recombinant human hyaluronidase PH20 (rHuPH20) sequentially.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 400 mg/mL; CAB 400 mg/mL administered intramascularly or subcutaneously.; Drug: Recombinant human hyaluronidase PH20 (rHuPH20); rHuPH20 administered subcutaneously.
Experimental: Part 1: Cohort 4h (C4h) CAB200 + rHuPH20; Following receipt of oral CAB 30 in the OLI phase, participants received one subcutaneous injection of 400 mg of CAB 200 mg/mL along with 5000 U of rHuPH20 sequentially.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 200 mg/mL; CAB 200 mg/mL administered intramascularly or subcutaneously.; Drug: Recombinant human hyaluronidase PH20 (rHuPH20); rHuPH20 administered subcutaneously.
Experimental: Part 2: Cohort 5 (C5) CAB400; Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 800 mg of CAB 400 mg/mL approximately 12 weeks apart.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 400 mg/mL; CAB 400 mg/mL administered intramascularly or subcutaneously.
Active Comparator: Part 2: Cohort 5 (C5) CAB200; Following receipt of oral CAB 30 in the OLI phase, participants received two intramuscular gluteal injections of 400 mg of CAB 200 mg/mL approximately 12 weeks apart. The dose was matched to the volume of CAB 400 mg/mL administered earlier in the same cohort.	Drug: Cabotegravir sodium (Oral Lead In); CAB 30 mg tablets administered orally.; Drug: Cabotegravir 200 mg/mL; CAB 200 mg/mL administered intramascularly or subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 Injection 1: Time of Maximum Observed Plasma Concentration (Tmax) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h	Blood samples were collected for Pharmacokinetic (PK) analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 1 - Day 1 to Week 4
Part 1 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b	Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Day 1 to Week 52 follow-up
Part 2 Injection 1: Tmax for CAB 400 mg/ml Formulation for Cohort 5	Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 1 - Day 1 to Week 12
Part 2 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohort 5	Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Day 1 to Week 52 follow-up
Part 1 Injection 2: Apparent Terminal Phase Half-life (T1/2) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b	Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Week 4 to Week 52 follow-up
Part 2 Injection 2: T1/2 for CAB 400 mg/ml Formulation for Cohort 5	Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Week 12 to Week 52 follow-up
Part 1 Injection 2: Terminal Absorption Elimination Rate Constant (KALA) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b	KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected at indicated time points. PK parameters were determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Week 4 to Week 52 follow-up
Part 2 Injection 2: KALA for CAB 400 mg/ml Formulation for Cohort 5	KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected at indicated time points. PK parameters were determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Week 12 to Week 52 follow-up
Part 1 Injection 1: Plasma Trough Concentrations (Ctau) of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h	Blood samples were collected for PK analysis of CAB. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR studies.	Injection 1 - Day 1 to Week 4
Part 1 Injection 2: Ctau of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b	Blood samples were collected for PK analysis of CAB. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR studies.	Injection 2 - Day 1 to Week 4
Part 2 Injection 1: Ctau of CAB 400 mg/ml Formulation for Cohort 5	Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. Ctau is the trough concentration at the end of the dosing interval. Ctau was expressed as geometric mean. For ATLAS /FLAIR: Historical data of CAB200 group, the geometric mean following dose normalization to 800mg was presented. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR and ECLAIRE studies.	Injection 1 - Day 1 to Week 12
Part 1 Injection 1: Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Time Point (AUC(0-t)) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h	Blood samples were collected for PK analysis of CAB. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 1 - Day 1 to Week 4
Part 1 Injection 2: AUC(0-t) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4 and 4b	Blood samples were collected for PK analysis of CAB. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Day 1 to Week 4
Part 1 Injection 1: Maximum Observed Plasma Concentration (Cmax) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h	The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 1 - Day 1 to Week 4
Part 1 Injection 2: Cmax of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b	The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.	Injection 2 - Day 1 to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and Part 2: Number of Participants With Adverse Events (AEs) in Injection Phase and Follow up Phase	An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The objective of this analysis is to present the data for participants that received at least an intramuscular or subcutaneous study injection of CAB 400 mg/mL or CAB 200 mg/mL with rHuPH20 formulation.	From Injection 1 day 1 up to 52 weeks follow-up
Part 1 and Part 2: Number of Participants With Liver Biochemistry Abnormalities in Injection Phase and Follow up Phase	Blood samples were collected at indicated timepoints to analyze the liver biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin and Direct Bilirubin. The objective of this analysis is to present the data for participants that received at least an intramuscular or subcutaneous study injection of CAB 400 mg/mL or CAB 200 mg/mL with rHuPH20 formulation.	From Injection 1 day 1 up to 52 weeks follow-up
Cmax for CAB Following Oral 30 mg Administration	Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods.	Up to Day 29
Tmax for CAB Following Oral 30 mg Administration	Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods.	Up to Day 29
AUC(0-t) for CAB Following Oral 30 mg Administration	Blood samples were collected for PK analysis of CAB after subcutaneous administration. The PK parameters were calculated by non-compartmental analysis.	Up to Day 29
Concentration at 24 Hours (C24) for CAB Following Oral 30 mg Administration		At 24 hours
Ctau for CAB Following Oral 30 mg Administration		Up to 24 hours on day 29 (Oral lead in phase)
Cmax of CAB 200 for Cohort 4h	Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameter was determined using standard non-compartmental methods.	Injection 1 - Day 1 to Week 52 follow-up
Tmax of CAB 200 for Cohort 4h	Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameter was determined using standard non-compartmental methods.	Injection 1 - Day 1 to Week 52 follow-up
AUC(0-t) of CAB 200 for Cohort 4h	Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameters were determined using standard non-compartmental methods.	Injection 1 - Day 1 to Week 52 follow-up
Ctau of CAB 200 for Cohort 4h and in ATLAS/FLAIR Study	Blood samples were collected for PK analysis of CAB after subcutaneous administration. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. Ctau was expressed as geometric mean. For ATLAS /FLAIR: Historical data of CAB200 group, the geometric mean following dose normalization to 400mg was presented.	Injection 1 - Day 1 to Week 52 follow-up
T1/2 of CAB 200 & CAB 400 for Cohort 4h	Blood samples were collected for PK analysis of CAB after subcutaneous administration. The PK parameters were calculated by non-compartmental analysis.	Injection 1 - Day 1 to Week 52 follow-up
KALA of CAB 200 & CAB 400 for Cohort 4h	KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameters were determined using standard non-compartmental methods.	Injection 1 - Day 1 to Week 52 follow-up

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Cabotegravir; Long-Acting Injection
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Polycyclic Compounds; Inorganic Chemicals; Fused-Ring Compounds; Elements; Metals; Metals, Heavy; Anti-Inflammatory Agents, Non-Steroidal; Lead; Steroids; cabotegravir
• Other Study ID Numbers: 212482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No