HIV InfectionsPhase 1NCT05418868
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
A Phase 1 study testing Cabotegravir 200 mg/mL, CAB >=400 mg/mL and CAB Formulation I in people with HIV Infections, run by ViiV Healthcare at 3 sites in United States.
Trial summary
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or… 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 200 mg/mL, CAB >=400 mg/mL and CAB Formulation I
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jun 2022to 31 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- At the time of obtaining informed consent, participants age should be greater than or equal to (>=)18 years and less than or equal to (<=) 55 years.
- 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).
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving written informed consent.
Who cannot join
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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.
- Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.
- 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.
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- 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) >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).
- Hemoglobin <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, including a known hypersensitivity to hyaluronidases.
- Current or anticipated need for chronic anti-coagulation therapy.
- Hereditary coagulation and platelet disorders (e.g., hemophilia 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, behavior 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.
- Participant 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.
- Fasting glucose >125 mg/dL (6.95 mmol/L; Grade >2) or in treatment for elevated blood glucose.
- Triglycerides >500 mg/dL (5.7 mmol/L; Grade >3) or in treatment for dyslipidemia.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Austin, Texas, 78744
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Las Vegas, Nevada, 89113-2235
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Completed
GSK Investigational Site
Orlando, Florida, 32806
About this study
Official title: A Phase I, Multi-centre, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Long-acting Cabotegravir Co-administered With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) >=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB >=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.
- Conditions
- HIV Infections
- Being tested
- Cabotegravir 200 mg/mL, CAB >=400 mg/mL, CAB Formulation I, CAB Formulation J, rHuPH20
- Keywords
- Cabotegravir (CAB), Rilpivirine (RPV), 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 200 mg/mLDrug
CAB 200 mg/mL will be administered.
CAB >=400 mg/mLDrug
CAB >=400 mg/mL will be administered by IM or SC injection.
CAB Formulation IDrug
CAB Formulation I will be administered by IM injection.
CAB Formulation JDrug
CAB Formulation J will be administered by IM injection.
rHuPH20Drug
rHuPH20 will be administered.
RPVDrug
RPV will be administered by IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Participants receiving CAB 200 mg/mL with rHuPH20 | Experimental | Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Receives: Drug: Cabotegravir 200 mg/mL; Drug: rHuPH20 |
| Part C: Participants receiving CAB >=400 mg/mL or CAB Formulation I or CAB Formulation J | Experimental | Not described Receives: Drug: CAB >=400 mg/mL; Drug: CAB Formulation I; Drug: CAB Formulation J |
| Part E: Participants receiving RPV | Experimental | Not described Receives: Drug: RPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of CAB and RPV
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Time of maximum observed plasma concentration (tmax) of CAB and RPV
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of CAB and RPV
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Area under the concentration - time curve from time zero to time of last quantifiable concentration or 4 weeks following the injection whichever is earlier (AUC[0-t]) of CAB and RPV
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Cohorts Part A, C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Area under the concentration - time curve from time zero to last quantifiable time point or 8 weeks following the injection whichever is earlier [AUC(0-t)]
Measured: Up to end of study (Week 72 for Cohort C10 and C12 [Part C])
Plasma Concentration of CAB and RPV at Week 4
Measured: Week 4
Plasma Concentration of CAB and RPV at Week 8
Measured: Week 8
Plasma Concentration of CAB and RPV at Week 12
Measured: Week 12
Plasma Concentration of CAB and RPV at Week 16
Measured: Week 16
Plasma Concentration of CAB and RPV at Week 24
Measured: Week 24
Plasma Concentration of RPV at Week 32
Measured: Week 32
Plasma Concentration of CAB at Week 36
Measured: Week 36
Plasma Concentration of RPV at Week 40
Measured: Week 40
Plasma Concentration of CAB and RPV at Week 48
Measured: Week 48
Plasma Concentration of CAB
Measured: At weeks 56, 64 and 72 for Cohorts C10, C11 and C12 [Part C]
Plasma Concentration of RPV at Week 56
Measured: Week 56
Plasma Concentration of RPV at Week 64
Measured: Week 64
Plasma Concentration of RPV at Week 72
Measured: Week 72
Apparent terminal phase half-life (t1/2) of CAB and RPV
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Apparent long-acting absorption rate constant (KA-LA) of CAB and RPV
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Number of Participants with Non-serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Number of Participants with AEs by Severity
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute value of hematology parameter: Platelet count (cells per microliter)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of hematology parameters: Reticulocytes (Percentage of reticulocytes)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of hematology parameters: Hematocrit (Proportion of red blood cells in blood)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of hematology parameters: Hemoglobin (Hgb) (grams per deciliter)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C] , and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute value of hematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute value of hematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute value of hematology parameter: Mean Corpuscle Hemoglobin (MCH) (Picograms)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
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 analyzed.
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameter: Platelet count (cells per microliter)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameters: Reticulocytes (Percentage of reticulocytes)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Cohorts Part A, C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameters: Hematocrit (Proportion of red blood cells in blood)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameters: Hgb (grams per deciliter)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameter: RBC Count (million cells per microliter)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameter: MCV (Femtoliters)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameter: MCH (picograms)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (Giga cells per liter)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in Clinical Chemistry parameters: Glucose (fasting), BUN, Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter)
Measured: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Number of participants with maximum toxicity grades increase from Baseline in hematology and clinical chemistry
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Secondary outcomes (7)
Dose proportionality of CAB and RPV based on AUC(0-inf)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Dose proportionality of CAB and RPV based on AUC(0-t)
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Dose proportionality of CAB and RPV based on Cmax
Measured: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Dose proportionality of CAB and RPV based on plasma concentration
Measured: Weeks 4, 8, 12 and 24
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 end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
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 end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
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 end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start14 Jun 2022
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
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
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, Janssen Sciences Ireland Unlimited Company
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418868
- Sponsor's protocol ID
- 218012
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_28May2026.pdf
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-centre, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Long-acting Cabotegravir Co-administered With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05418868
- Acronym / sponsor ID
- 218012
- Conditions
- HIV Infections
- Keywords
- Cabotegravir (CAB), Rilpivirine (RPV), Long-Acting Injection, Pharmacokinetics, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, Janssen Sciences Ireland Unlimited Company
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 14 Jun 2022 (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.
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) >=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB >=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Participants receiving CAB 200 mg/mL with rHuPH20 | Experimental | Drug: Cabotegravir 200 mg/mL, Drug: rHuPH20Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. |
| Part C: Participants receiving CAB >=400 mg/mL or CAB Formulation I or CAB Formulation J | Experimental | Drug: CAB >=400 mg/mL, Drug: CAB Formulation I, Drug: CAB Formulation J |
| Part E: Participants receiving RPV | Experimental | Drug: RPV |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- At the time of obtaining informed consent, participants age should be greater than or equal to (>=)18 years and less than or equal to (<=) 55 years.
- 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).
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving written informed consent.
Key exclusion criteria (29 listed)
- Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, 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.
- Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.
- 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.
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 200 mg/mLCAB 200 mg/mL will be administered. | Drug | Part A: Participants receiving CAB 200 mg/mL with rHuPH20 |
| CAB >=400 mg/mLCAB >=400 mg/mL will be administered by IM or SC injection. | Drug | Part C: Participants receiving CAB >=400 mg/mL or CAB Formulation I or CAB Formulation J |
| CAB Formulation ICAB Formulation I will be administered by IM injection. | Drug | Part C: Participants receiving CAB >=400 mg/mL or CAB Formulation I or CAB Formulation J |
| CAB Formulation JCAB Formulation J will be administered by IM injection. | Drug | Part C: Participants receiving CAB >=400 mg/mL or CAB Formulation I or CAB Formulation J |
| rHuPH20rHuPH20 will be administered. | Drug | Part A: Participants receiving CAB 200 mg/mL with rHuPH20 |
| RPVRPV will be administered by IM injection. | Drug | Part E: Participants receiving RPV |
Primary outcome
Maximum observed plasma concentration (Cmax) of CAB and RPV
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Time of maximum observed plasma concentration (tmax) of CAB and RPV
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of CAB and RPV
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Area under the concentration - time curve from time zero to time of last quantifiable concentration or 4 weeks following the injection whichever is earlier (AUC[0-t]) of CAB and RPV
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Cohorts Part A, C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Area under the concentration - time curve from time zero to last quantifiable time point or 8 weeks following the injection whichever is earlier [AUC(0-t)]
Time frame: Up to end of study (Week 72 for Cohort C10 and C12 [Part C])
Plasma Concentration of CAB and RPV at Week 4
Time frame: Week 4
Plasma Concentration of CAB and RPV at Week 8
Time frame: Week 8
Plasma Concentration of CAB and RPV at Week 12
Time frame: Week 12
Plasma Concentration of CAB and RPV at Week 16
Time frame: Week 16
Plasma Concentration of CAB and RPV at Week 24
Time frame: Week 24
Plasma Concentration of RPV at Week 32
Time frame: Week 32
Plasma Concentration of CAB at Week 36
Time frame: Week 36
Plasma Concentration of RPV at Week 40
Time frame: Week 40
Plasma Concentration of CAB and RPV at Week 48
Time frame: Week 48
Plasma Concentration of CAB
Time frame: At weeks 56, 64 and 72 for Cohorts C10, C11 and C12 [Part C]
Plasma Concentration of RPV at Week 56
Time frame: Week 56
Plasma Concentration of RPV at Week 64
Time frame: Week 64
Plasma Concentration of RPV at Week 72
Time frame: Week 72
Apparent terminal phase half-life (t1/2) of CAB and RPV
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Apparent long-acting absorption rate constant (KA-LA) of CAB and RPV
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Number of Participants with Non-serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Number of Participants with AEs by Severity
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute value of hematology parameter: Platelet count (cells per microliter)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of hematology parameters: Reticulocytes (Percentage of reticulocytes)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of hematology parameters: Hematocrit (Proportion of red blood cells in blood)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of hematology parameters: Hemoglobin (Hgb) (grams per deciliter)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C] , and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute value of hematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute value of hematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute value of hematology parameter: Mean Corpuscle Hemoglobin (MCH) (Picograms)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
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 analyzed.
Absolute values of Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameter: Platelet count (cells per microliter)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameters: Reticulocytes (Percentage of reticulocytes)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Cohorts Part A, C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameters: Hematocrit (Proportion of red blood cells in blood)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameters: Hgb (grams per deciliter)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameter: RBC Count (million cells per microliter)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameter: MCV (Femtoliters)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameter: MCH (picograms)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (Giga cells per liter)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in Clinical Chemistry parameters: Glucose (fasting), BUN, Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Change from Baseline in Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter)
Time frame: Baseline (Day 1) and up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Number of participants with maximum toxicity grades increase from Baseline in hematology and clinical chemistry
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
7 secondary outcomes
Dose proportionality of CAB and RPV based on AUC(0-inf)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Dose proportionality of CAB and RPV based on AUC(0-t)
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Dose proportionality of CAB and RPV based on Cmax
Time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Dose proportionality of CAB and RPV based on plasma concentration
Time frame: Weeks 4, 8, 12 and 24
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 end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
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 end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
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 end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_28May2026.pdf
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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.
GSK Clinical Trials study director
ViiV Healthcare
3 sites 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 200 mg/mL, CAB >=400 mg/mL and CAB Formulation I in people with HIV Infections, run by ViiV Healthcare at 3 sites 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 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) of CAB and RPV (time frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10, C11 and C12 [Part C])). The study lists 45 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 4 Nov 2026.