HIV InfectionsPhase 1NCT04484337
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 study testing Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL and Cabotegravir 200 mg/mL in people with HIV Infections, run by ViiV Healthcare at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL and Cabotegravir 200 mg/mL
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 31 Jul 2020to 5 May 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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%).
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- 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.
- Heart rate: For Males <45 or >100 beats per minute (bpm), for females <50 or >100 bpm.
- PR Interval: For males and females <120 or >220 msec.
- QRS duration: For males and females <70 or >120 msec.
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
GSK Investigational Site
Austin, Texas, 78744
GSK Investigational Site
Berlin, New Jersey, 08009
GSK Investigational Site
Las Vegas, Nevada, 89113
GSK Investigational Site
Orlando, Florida, 32806
About this study
Official title: 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.
- Conditions
- HIV Infections
- Being tested
- Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL, Cabotegravir 200 mg/mL, Topical Non-steroidal anti-inflammatory drug (NSAID), Topical steroid
- Keywords
- Cabotegravir, Long-Acting Injection, Pharmacokinetics, Safety, Tolerability
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir sodium (Oral Lead In)Drug
CAB 30 mg tablets administered orally.
Cabotegravir 400 mg/mLDrug
CAB 400 mg/mL administered intramascularly or subcutaneously.
Cabotegravir 200 mg/mLDrug
CAB 200 mg/mL administered intramascularly or subcutaneously.
Topical Non-steroidal anti-inflammatory drug (NSAID)Drug
NSAID applied topically.
Topical steroidDrug
Steroid medication applied topically.
Topical NSAID placeboDrug
Placebo for NSAID applied topically.
Recombinant human hyaluronidase PH20 (rHuPH20)Drug
rHuPH20 administered subcutaneously.
Topical steroid placeboDrug
Placebo for steroid applied topically.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cabotegravir (CAB) 30 | Experimental | Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase. Receives: Drug: Cabotegravir sodium (Oral Lead In) |
| Part 1: Cohort 1 (C1) CAB 400 | Experimental | Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL |
| Part 1: Cohort 1 (C1) CAB200 | Active comparator | Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the gluteus medius, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 200 mg/mL |
| Part 1: Cohort 2 (C2) CAB400 | Experimental | Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) subcutaneously in the abdomen, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL |
| Part 1: Cohort 2 (C2) CAB200 | Active comparator | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 200 mg/mL |
| Part 1: Cohort 3 (C3) CAB400 | Experimental | Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 400 milligram per milliliter (mg/mL) (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL |
| Part 1: Cohort 3 (C3) CAB200 | Active comparator | Following receipt of oral CAB 30 in the OLI phase, participants received two injections of CAB 200 mg/mL (Injection 1: 600 mg and Injection 2: 400 mg respectively) intramuscularly in the lateral thigh, at Day 1 of Injection Phase and approximately at Week 4 of Injection Phase. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 200 mg/mL |
| Part 1: Cohort 4 (C4) CAB400 | Experimental | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL |
| Part 1: Cohort 4 (C4) CAB200 | Active comparator | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 200 mg/mL |
| Part 1: Cohort 4b Group 1 (C4b G1) | Experimental | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL; Drug: Topical Non-steroidal anti-inflammatory drug (NSAID); Drug: Topical steroid; Drug: Topical NSAID placebo; Drug: Topical steroid placebo |
| Part 1: Cohort 4b Group 2 (C4b G2) | Experimental | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL; Drug: Topical Non-steroidal anti-inflammatory drug (NSAID); Drug: Topical steroid; Drug: Topical NSAID placebo; Drug: Topical steroid placebo |
| Part 1: Cohort 4h (C4h) CAB400 + rHuPH20 | Experimental | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL; Drug: Recombinant human hyaluronidase PH20 (rHuPH20) |
| Part 1: Cohort 4h (C4h) CAB200 + rHuPH20 | Experimental | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 200 mg/mL; Drug: Recombinant human hyaluronidase PH20 (rHuPH20) |
| Part 2: Cohort 5 (C5) CAB400 | Experimental | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 400 mg/mL |
| Part 2: Cohort 5 (C5) CAB200 | Active comparator | 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. Receives: Drug: Cabotegravir sodium (Oral Lead In); Drug: Cabotegravir 200 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Injection 2 - Day 1 to Week 4
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 29
Concentration at 24 Hours (C24) for CAB Following Oral 30 mg Administration
Measured: At 24 hours
Ctau for CAB Following Oral 30 mg Administration
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Injection 1 - Day 1 to Week 52 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start31 Jul 2020
- Primary completion5 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484337
- Sponsor's protocol ID
- 212482
- Status last verified
- Feb 2026
- First submitted
- 20 Jul 2020
- Last updated
- 29 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Han K, Benn P, Sievers J, Dorey D, Warwick-Sanders M, Hareedy R, Harkness L, Leemereise C, Offenbecker K, Donatti C, Brimhall DB, Schwabe C, Boyle C, Hassman MA, Knowles S, D'Amico R, Spreen WR. A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV. Clin Pharmacol Drug Dev. 2025 Jul;14(7):528-541. doi: 10.1002/cpdd.1538. Epub 2025 Apr 29.
PubMed 40296638
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04484337
- Acronym / sponsor ID
- 212482
- Conditions
- HIV Infections
- Keywords
- Cabotegravir, Long-Acting Injection, Pharmacokinetics, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Posted 29 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Oral Cabotegravir (CAB) 30 | Experimental | Drug: Cabotegravir sodium (Oral Lead In)Participants received oral dose of CAB 30 milligram (mg) tablet once daily for Days 1 to 28 in the oral lead in phase. |
| Part 1: Cohort 1 (C1) CAB 400 | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 400 mg/mLFollowing 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. |
| Part 1: Cohort 1 (C1) CAB200 | Active comparator | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 200 mg/mLFollowing 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. |
| Part 1: Cohort 2 (C2) CAB400 | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 400 mg/mLFollowing 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. |
| Part 1: Cohort 2 (C2) CAB200 | Active comparator | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 200 mg/mLFollowing 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. |
| Part 1: Cohort 3 (C3) CAB400 | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 400 mg/mLFollowing 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. |
| Part 1: Cohort 3 (C3) CAB200 | Active comparator | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 200 mg/mLFollowing 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. |
| Part 1: Cohort 4 (C4) CAB400 | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 400 mg/mLFollowing 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. |
| Part 1: Cohort 4 (C4) CAB200 | Active comparator | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 200 mg/mLFollowing 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. |
| Part 1: Cohort 4b Group 1 (C4b G1) | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 400 mg/mL, Drug: Topical Non-steroidal anti-inflammatory drug (NSAID), Drug: Topical steroid, Drug: Topical NSAID placebo, Drug: Topical steroid placeboFollowing 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. |
| Part 1: Cohort 4b Group 2 (C4b G2) | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 400 mg/mL, Drug: Topical Non-steroidal anti-inflammatory drug (NSAID), Drug: Topical steroid, Drug: Topical NSAID placebo, Drug: Topical steroid placeboFollowing 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. |
| Part 1: Cohort 4h (C4h) CAB400 + rHuPH20 | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 400 mg/mL, Drug: Recombinant human hyaluronidase PH20 (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. |
| Part 1: Cohort 4h (C4h) CAB200 + rHuPH20 | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 200 mg/mL, Drug: Recombinant human hyaluronidase PH20 (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. |
| Part 2: Cohort 5 (C5) CAB400 | Experimental | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 400 mg/mLFollowing 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. |
| Part 2: Cohort 5 (C5) CAB200 | Active comparator | Drug: Cabotegravir sodium (Oral Lead In), Drug: Cabotegravir 200 mg/mLFollowing 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (37 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir sodium (Oral Lead In)CAB 30 mg tablets administered orally. | Drug | Oral Cabotegravir (CAB) 30, Part 1: Cohort 1 (C1) CAB 400, Part 1: Cohort 1 (C1) CAB200, Part 1: Cohort 2 (C2) CAB200, Part 1: Cohort 2 (C2) CAB400, Part 1: Cohort 3 (C3) CAB200, Part 1: Cohort 3 (C3) CAB400, Part 1: Cohort 4 (C4) CAB200, Part 1: Cohort 4 (C4) CAB400, Part 1: Cohort 4b Group 1 (C4b G1), Part 1: Cohort 4b Group 2 (C4b G2), Part 1: Cohort 4h (C4h) CAB200 + rHuPH20, Part 1: Cohort 4h (C4h) CAB400 + rHuPH20, Part 2: Cohort 5 (C5) CAB200, Part 2: Cohort 5 (C5) CAB400 |
| Cabotegravir 400 mg/mLCAB 400 mg/mL administered intramascularly or subcutaneously. | Drug | Part 1: Cohort 1 (C1) CAB 400, Part 1: Cohort 2 (C2) CAB400, Part 1: Cohort 3 (C3) CAB400, Part 1: Cohort 4 (C4) CAB400, Part 1: Cohort 4b Group 1 (C4b G1), Part 1: Cohort 4b Group 2 (C4b G2), Part 1: Cohort 4h (C4h) CAB400 + rHuPH20, Part 2: Cohort 5 (C5) CAB400 |
| Cabotegravir 200 mg/mLCAB 200 mg/mL administered intramascularly or subcutaneously. | Drug | Part 1: Cohort 1 (C1) CAB200, Part 1: Cohort 2 (C2) CAB200, Part 1: Cohort 3 (C3) CAB200, Part 1: Cohort 4 (C4) CAB200, Part 1: Cohort 4h (C4h) CAB200 + rHuPH20, Part 2: Cohort 5 (C5) CAB200 |
| Topical Non-steroidal anti-inflammatory drug (NSAID)NSAID applied topically. | Drug | Part 1: Cohort 4b Group 1 (C4b G1), Part 1: Cohort 4b Group 2 (C4b G2) |
| Topical steroidSteroid medication applied topically. | Drug | Part 1: Cohort 4b Group 1 (C4b G1), Part 1: Cohort 4b Group 2 (C4b G2) |
| Topical NSAID placeboPlacebo for NSAID applied topically. | Drug | Part 1: Cohort 4b Group 1 (C4b G1), Part 1: Cohort 4b Group 2 (C4b G2) |
| Recombinant human hyaluronidase PH20 (rHuPH20)rHuPH20 administered subcutaneously. | Drug | Part 1: Cohort 4h (C4h) CAB200 + rHuPH20, Part 1: Cohort 4h (C4h) CAB400 + rHuPH20 |
| Topical steroid placeboPlacebo for steroid applied topically. | Drug | Part 1: Cohort 4b Group 1 (C4b G1), Part 1: Cohort 4b Group 2 (C4b G2) |
Primary outcome
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
Time frame: Injection 1 - Day 1 to Week 4
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.
Part 1 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b
Time frame: Injection 2 - Day 1 to Week 52 follow-up
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.
Part 2 Injection 1: Tmax for CAB 400 mg/ml Formulation for Cohort 5
Time frame: Injection 1 - Day 1 to Week 12
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.
Part 2 Injection 2: Tmax for CAB 400 mg/ml Formulation for Cohort 5
Time frame: Injection 2 - Day 1 to Week 52 follow-up
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.
Part 1 Injection 2: Apparent Terminal Phase Half-life (T1/2) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b
Time frame: Injection 2 - Week 4 to Week 52 follow-up
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.
Part 2 Injection 2: T1/2 for CAB 400 mg/ml Formulation for Cohort 5
Time frame: Injection 2 - Week 12 to Week 52 follow-up
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.
Part 1 Injection 2: Terminal Absorption Elimination Rate Constant (KALA) for CAB 400 mg/ml Formulation for Cohorts 1,2,3,4 & 4b
Time frame: Injection 2 - Week 4 to Week 52 follow-up
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.
Part 2 Injection 2: KALA for CAB 400 mg/ml Formulation for Cohort 5
Time frame: Injection 2 - Week 12 to Week 52 follow-up
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.
Part 1 Injection 1: Plasma Trough Concentrations (Ctau) of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b & 4h
Time frame: Injection 1 - Day 1 to Week 4
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.
Part 1 Injection 2: Ctau of CAB 400 mg/ml Formulation for Cohorts 1,2,3,4, 4b
Time frame: Injection 2 - Day 1 to Week 4
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.
Part 2 Injection 1: Ctau of CAB 400 mg/ml Formulation for Cohort 5
Time frame: Injection 1 - Day 1 to Week 12
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.
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
Time frame: Injection 1 - Day 1 to Week 4
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.
Part 1 Injection 2: AUC(0-t) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4 and 4b
Time frame: Injection 2 - Day 1 to Week 4
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.
Part 1 Injection 1: Maximum Observed Plasma Concentration (Cmax) of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b and 4h
Time frame: Injection 1 - Day 1 to Week 4
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.
Part 1 Injection 2: Cmax of CAB 400 mg/ml Formulation for Cohorts 1, 2, 3, 4, 4b
Time frame: Injection 2 - Day 1 to Week 4
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.
13 secondary outcomes
Part 1 and Part 2: Number of Participants With Adverse Events (AEs) in Injection Phase and Follow up Phase
Time frame: 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
Time frame: From Injection 1 day 1 up to 52 weeks follow-up
Cmax for CAB Following Oral 30 mg Administration
Time frame: Up to Day 29
Tmax for CAB Following Oral 30 mg Administration
Time frame: Up to Day 29
AUC(0-t) for CAB Following Oral 30 mg Administration
Time frame: Up to Day 29
Concentration at 24 Hours (C24) for CAB Following Oral 30 mg Administration
Time frame: At 24 hours
Ctau for CAB Following Oral 30 mg Administration
Time frame: Up to 24 hours on day 29 (Oral lead in phase)
Cmax of CAB 200 for Cohort 4h
Time frame: Injection 1 - Day 1 to Week 52 follow-up
Tmax of CAB 200 for Cohort 4h
Time frame: Injection 1 - Day 1 to Week 52 follow-up
AUC(0-t) of CAB 200 for Cohort 4h
Time frame: Injection 1 - Day 1 to Week 52 follow-up
Ctau of CAB 200 for Cohort 4h and in ATLAS/FLAIR Study
Time frame: Injection 1 - Day 1 to Week 52 follow-up
T1/2 of CAB 200 & CAB 400 for Cohort 4h
Time frame: Injection 1 - Day 1 to Week 52 follow-up
KALA of CAB 200 & CAB 400 for Cohort 4h
Time frame: Injection 1 - Day 1 to Week 52 follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40296638Han K, Benn P, Sievers J, Dorey D, Warwick-Sanders M, Hareedy R, Harkness L, Leemereise C, Offenbecker K, Donatti C, Brimhall DB, Schwabe C, Boyle C, Hassman MA, Knowles S, D'Amico R, Spreen WR. A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV. Clin Pharmacol Drug Dev. 2025 Jul;14(7):528-541. doi: 10.1002/cpdd.1538. Epub 2025 Apr 29.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL and Cabotegravir 200 mg/mL in people with HIV Infections, run by ViiV Healthcare at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Injection 1 - Day 1 to Week 4). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04484337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.