HIV InfectionsPhase 1NCT06033547
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants
A Phase 1 study testing Cabotegravir Formulation F and Cabotegravir Formulation G in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants. The study will initially start with the assessment of Cabotegravir Formulation F. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cabotegravir Formulation F and Cabotegravir Formulation G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 25 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body weight =>40 kilogram (kg) and body mass index (BMI) within the range =>18 to =<32 kilogram per meter square (kg/m^2)
- Participants who are negative on a single test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)(approved molecular polymerase chain reaction [PCR] laboratory or point of care test) performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP) OR
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- Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1% from the time of screening and inclusive of the entire time while on the study.
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within the 30 days before the first dose of study intervention.
- Capable of giving written informed consent
Who cannot join
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- 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.
- Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
- Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms which in the opinion of the investigator are suggestive of COVID-19 (i.e., fever, cough etc) within 14 days of inpatient admission, or having contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission.
- Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.
Show all 29Show fewer
- History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, 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.
- 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.
- Abnormal blood pressure.
- 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).
- Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant.
- One or more exclusionary values for a screening Electrocardiogram (ECG).
- Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
- Estimated Glomerular Filtration Rate (eGFR) <60 milliliter per minute (mL/min) using the Chronic Kidney Disease - Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021).
- Haemoglobin <12.5 gram per deciliter (g/dL) for men and <11 g/dL for women.
- Positive pre-study drug/alcohol screen.
- Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches or vaporizing devices).
- 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.
- Regular use of known drugs of abuse.
- Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in this 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.
- Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day.
- History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation
- Current or anticipated need for chronic anti-coagulation therapy (with the exception of low-dose aspirin =< 325 mg/day)
- Hereditary coagulation and platelet disorders (e.g., haemophilia or Von Willebrand disease [VWD]).
- Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that, in the opinion of the investigator, may interfere with interpretation of injection site reactions or administration of study intervention.
- Any other clinical condition, behaviour or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Two Different Formulations of Long-acting Cabotegravir Administered to Healthy Adult Participants
The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants. The study will initially start with the assessment of Cabotegravir Formulation F. Once the clinical batch of Cabotegravir Formulation G is available, this formulation will be assessed.
- Conditions
- HIV Infections
- Being tested
- Cabotegravir Formulation F, Cabotegravir Formulation G
- Keywords
- Cabotegravir, Pharmacokinetics
- 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 Formulation FDrug
Cabotegravir Formulation F will be administered
Cabotegravir Formulation GDrug
Cabotegravir Formulation G will be administered
| Study group | Role | What they receive |
|---|---|---|
| Part A: Participants receiving Cabotegravir Formulation F | Experimental | Not described Receives: Drug: Cabotegravir Formulation F |
| Part B: Participants receiving Cabotegravir Formulation G | Experimental | Not described Receives: Drug: Cabotegravir Formulation G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of cabotegravir
Measured: Up to Week 52
Time of maximum observed plasma concentration (tmax) of cabotegravir
Measured: Up to Week 52
Area under the concentration - time curve from time zero to 4 weeks following the injection (AUC[0-4]) of cabotegravir
Measured: Up to Week 4
Plasma Concentration of cabotegravir at Week 4
Measured: Week 4
Number of participants with adverse events (AEs) based on severity
Measured: Up to Week 52
Absolute value of haematology parameter: Platelet count (cells per microliter)
Measured: Up to Week 52
Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Measured: Up to Week 52
Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre)
Measured: Up to Week 52
Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood)
Measured: Up to Week 52
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Measured: Up to Week 52
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Measured: Up to Week 52
Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes)
Measured: Up to Week 52
Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Measured: Up to Week 52
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Measured: Up to Week 52
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed.
Measured: Up to Week 52
Absolute values of Clinical chemistry parameters: Total Protein (Grams per deciliter)
Measured: Up to Week 52
Absolute values of Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR2) (millilitres per minute)
Measured: Up to Week 52
Change from Baseline in haematology parameter: Platelet count (cells per microliter)
Measured: Baseline (Day 1) and up to Week 52
Change from Baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes)
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical chemistry parameters: Total Protein (Grams per deciliter)
Measured: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR) (millilitres per minute)
Measured: Baseline (Day 1) and up to Week 52
Secondary outcomes (9)
Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of cabotegravir
Measured: Up to Week 52
Area under the concentration - time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of cabotegravir
Measured: Up to Week 52
Plasma Concentration of cabotegravir at Week 8,12 and 24
Measured: Week 8, 12 and 24
Apparent terminal phase half-life (t1/2) of cabotegravir
Measured: Up to Week 52
Apparent long-acting absorption rate constant (KA-LA) of cabotegravir
Measured: Up to Week 52
Dose proportionality of cabotegravir based on AUC(0-inf), AUC(0-last), Cmax, and plasma concentration (Unit of measure: Slope of log dose)
Measured: Up to Week 52
Number of participants with maximum post-baseline QTc values compared to baseline by category (to <=450 milliseconds (msec) or no change, to >450 msec to <=480 msec, to >480 msec to <=500 msec, and to >500 msec)
Measured: Up to Week 52
Number of participants with maximum post-baseline increase in QTc values compared to baseline based on category (increase <=30 msec, increase of 31-60 msec, and increase of >60 msec)
Measured: Up to Week 52
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline will be categorized into change to low, change to within range or no change, and change to high
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start12 Sep 2023
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033547
- Sponsor's protocol ID
- 219406
- Status last verified
- Feb 2026
- First submitted
- 31 Aug 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Two Different Formulations of Long-acting Cabotegravir Administered to Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06033547
- Acronym / sponsor ID
- 219406
- Conditions
- HIV Infections
- Keywords
- Cabotegravir, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants. The study will initially start with the assessment of Cabotegravir Formulation F. Once the clinical batch of Cabotegravir Formulation G is available, this formulation will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Participants receiving Cabotegravir Formulation F | Experimental | Drug: Cabotegravir Formulation F |
| Part B: Participants receiving Cabotegravir Formulation G | Experimental | Drug: Cabotegravir Formulation G |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body weight =>40 kilogram (kg) and body mass index (BMI) within the range =>18 to =<32 kilogram per meter square (kg/m^2)
- Participants who are negative on a single test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)(approved molecular polymerase chain reaction [PCR] laboratory or point of care test) performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Participants assigned female at birth are eligible to participate if they are not pregnant or breastfeeding, and at least one of the following conditions applies:
Key exclusion criteria (29 listed)
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- 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.
- Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
- Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms which in the opinion of the investigator are suggestive of COVID-19 (i.e., fever, cough etc) within 14 days of inpatient admission, or having contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission.
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 Formulation FCabotegravir Formulation F will be administered | Drug | Part A: Participants receiving Cabotegravir Formulation F |
| Cabotegravir Formulation GCabotegravir Formulation G will be administered | Drug | Part B: Participants receiving Cabotegravir Formulation G |
Primary outcome
Maximum observed plasma concentration (Cmax) of cabotegravir
Time frame: Up to Week 52
Time of maximum observed plasma concentration (tmax) of cabotegravir
Time frame: Up to Week 52
Area under the concentration - time curve from time zero to 4 weeks following the injection (AUC[0-4]) of cabotegravir
Time frame: Up to Week 4
Plasma Concentration of cabotegravir at Week 4
Time frame: Week 4
Number of participants with adverse events (AEs) based on severity
Time frame: Up to Week 52
Absolute value of haematology parameter: Platelet count (cells per microliter)
Time frame: Up to Week 52
Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Time frame: Up to Week 52
Absolute values of haematology parameters: haemoglobin (Hgb) (grams per decilitre)
Time frame: Up to Week 52
Absolute values of haematology parameters: haematocrit (Proportion of red blood cells in blood)
Time frame: Up to Week 52
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Time frame: Up to Week 52
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Time frame: Up to Week 52
Absolute values of haematology parameters: Reticulocytes (Percentage of reticulocytes)
Time frame: Up to Week 52
Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Time frame: Up to Week 52
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Time frame: Up to Week 52
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Time frame: Up to Week 52
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed.
Absolute values of Clinical chemistry parameters: Total Protein (Grams per deciliter)
Time frame: Up to Week 52
Absolute values of Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR2) (millilitres per minute)
Time frame: Up to Week 52
Change from Baseline in haematology parameter: Platelet count (cells per microliter)
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: Reticulocytes (Percentage of reticulocytes)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in haematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per litre)
Time frame: Baseline (Day 1) and up to Week 52
Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analysed
Change from baseline in Clinical chemistry parameters: Total Protein (Grams per deciliter)
Time frame: Baseline (Day 1) and up to Week 52
Change from baseline in Clinical chemistry parameters: Estimated Glomerular Filtration Rate (eGFR) (millilitres per minute)
Time frame: Baseline (Day 1) and up to Week 52
9 secondary outcomes
Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of cabotegravir
Time frame: Up to Week 52
Area under the concentration - time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of cabotegravir
Time frame: Up to Week 52
Plasma Concentration of cabotegravir at Week 8,12 and 24
Time frame: Week 8, 12 and 24
Apparent terminal phase half-life (t1/2) of cabotegravir
Time frame: Up to Week 52
Apparent long-acting absorption rate constant (KA-LA) of cabotegravir
Time frame: Up to Week 52
Dose proportionality of cabotegravir based on AUC(0-inf), AUC(0-last), Cmax, and plasma concentration (Unit of measure: Slope of log dose)
Time frame: Up to Week 52
Number of participants with maximum post-baseline QTc values compared to baseline by category (to <=450 milliseconds (msec) or no change, to >450 msec to <=480 msec, to >480 msec to <=500 msec, and to >500 msec)
Time frame: Up to Week 52
Number of participants with maximum post-baseline increase in QTc values compared to baseline based on category (increase <=30 msec, increase of 31-60 msec, and increase of >60 msec)
Time frame: Up to Week 52
Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate
Time frame: Up to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabotegravir Formulation F and Cabotegravir Formulation G in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
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 9 inclusion and 29 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum observed plasma concentration (Cmax) of cabotegravir (time frame: Up to Week 52). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.