HIV InfectionsPhase 1NCT03422172

A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men

A Phase 1 study testing Oral CAB and CAB LA in people with HIV Infections, run by ViiV Healthcare at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Oral CAB and CAB LA
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 3 sitesChina
Study dates: 10 Apr 2018to 20 Apr 2020
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 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
Subjects are male at birth.
Subjects who have non-reactive point of care (POC) HIV test and undetectable HIV-1 ribose nucleic acid (RNA) at screening.
At risk of acquiring HIV, defined as having at least one casual male or female sex partner in the past 24 months.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening.
Capable of giving written informed consent.
Agree to appropriate use of contraceptive measures during heterosexual intercourse. All subjects should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (example given (e.g.), male condom) to reduce the risk of sexually transmitted infections.
Willing to undergo all required study procedures.

Who cannot join

Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia.
Active skin disease or disorder (that is [i.e.], infection, inflammation, dermatitis, eczema, drug rash, psoriasis, urticaria). Mild cases of localized acne or folliculitis or other mild skin condition may not be exclusionary at the discretion of the Investigator of Record or Medical Monitor.
Subjects determined by the Investigator to have a high risk of seizures, including subjects with an unstable or poorly controlled seizure disorder. A subject with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment.
Any medical condition, including psychiatric conditions that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
Subjects who, in the investigator's judgment, poses a significant suicide risk.

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Use of antiretroviral (ARV) therapy (e.g., for Post exposure prophylaxis [PEP] or PrEP) in the past 30 days.
Use of high dose aspirin or any other anticoagulant or antiplatelet medication that would interfere with the ability to receive IM injections.
Assessed by the Investigator of Record or designee as being at "high risk" for HIV infection. This may include one or more of the following: the negative partner in an HIV serodiscordant couple where the HIV infected partner is not suppressed; men who exchange sex for goods or money; men who have engaged in any condomless anal intercourse within the past 6 months; men who have had greater than 5 male or female sexual partners within the past 6 months; men who have had a sexually transmitted disease within the past 6 months; any other behavior assessed by the investigator as "high risk".
History of drug or alcohol consumption that in the opinion of the Principal Investigator will interfere with study participation.
Ongoing intravenous drug use - episodic use or any use in the past 90 days is exclusionary (as assessed by the study investigator).
One or more reactive HIV test results at screening or enrolment, even if HIV infection is not confirmed. Negative HIV RNA must also be documented at screening.
Co-enrolment in any other HIV interventional research study (provided by self-report or other available documentation) or prior enrolment and receipt of the active arm (i.e., NOT a placebo) of a HIV vaccine trial (provided by available documentation).
Any of the following laboratory values during the screening period: positive hepatitis C antibody result; positive Hepatitis B surface antigen (HBsAg); hemoglobin <11 grams per deciliter (g/dL); absolute neutrophil count <750 cells/ cubic millimeter (mm^3); platelet count <=100,000 cells/mm^3; presence of a coagulopathy as defined by an international normalized ratio(INR)>1.5 or a partial thromboplastin time (PTT) >45 seconds; calculated creatinine clearance <60 milliliter/minute (mL/minute) using the Cockcroft-Gault equation; a single repeat test is allowed during the screening period to verify a result, with the exception of HIV tests.
Subjects with an ALT, alkaline phosphatase or bilirubin >=1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
The subject has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.

Trial locations and contacts

3 sites in 1 country.

China3 sites

GSK Investigational Site
Beijing, 100069
GSK Investigational Site
Hangzhou, Zhejiang, 310000
GSK Investigational Site
Shanghai, 201508

Other trials in China

About this study

Official title: An Open Label, Phase 1 Study to Evaluate the PK, Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, Cabotegravir (CAB; GSK1265744) in HIV Uninfected Chinese Men

The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and prevention of HIV infection. CAB possesses attributes that allow formulation and delivery as a LA parenteral product. CAB is being developed as both oral and long acting (LA) injectable formulations. This study is designed to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during injection phase of the study. Approximately 60 subjects will be screened, of which, approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection phase of the study. The maximum study duration will be approximately 89 weeks including oral phase, injection phase and follow-up phase.

Conditions: HIV Infections
Being tested: Oral CAB, CAB LA
Keywords: GSK1265744, Pre-Exposure Prophylaxis, Human immunodeficiency virus, Cabotegravir, Pharmacokinetics
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral CABDrug
CAB tablet will be formulated as white to almost white, oval shaped, film coated 30 mg tablets, administered orally once daily. The CAB tablets will be packaged in bottles containing 30 tablets each.
CAB LADrug
CAB LA is a sterile white to slightly colored suspension containing 200 mg/mL of CAB as free acid for administration by IM injection in gluteus medius.

Study groups in NCT03422172
Study group	Role	What they receive
Subjects receiving CAB	Experimental	Eligible subjects will receive oral doses of CAB 30 milligrams (mg) tablets once daily for 4 weeks followed by IM injectable suspension of CAB LA 600 mg at Week 5, Week 9, Week 17, Week 25 and Week 33. There will be an approximately 1-week washout period between the last oral dose and the first injection of CAB at Week 5. Receives: Drug: Oral CAB; Drug: CAB LA

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs): Injection Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or other situations as per investigator's judgement.
Measured: Week 5 to 41
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Hematology parameters were graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: Activated partial thromboplastin time (APTT) prolonged, hemoglobin (Hb) (increased), white blood cells (WBC) (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Measured: Week 5 to 41
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), bilirubin, calcium (hypercalcemia and hypocalcemia), carbon dioxide (CO2) (decreased), cholesterol (high), Creatine phosphokinase (CPK) increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Measured: Week 5 to 41
Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Measured: Week 5 to 41
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: systolic blood pressure (SBP) (Low: <85 millimeters of mercury [mmHg], High: >160 mmHg), diastolic blood pressure (DBP) (Low: <45 mmHg, High: >100 mmHg), pulse rate (Low: <40 mmHg, High: >100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Week 5 to 41
Number of Participants Withdrawn Due to AEs- Injection Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
Measured: Week 5 to 41
Number of Participants Experiencing Injection Site Reactions (ISR)-Injection Phase
Injection site reactions were recorded via ISR diaries and managed through investigator assessment. Number of participants who experienced any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) is presented.
Measured: Week 5 to 41
Concentration of Cabotegravir in Plasma at the End of the Dosing Interval (Ctau)-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Ctau following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Measured: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Dosing of Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Measured: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Maximum Observed Concentration (Cmax) Following Oral Dosing With Cabogegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Cmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Measured: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Time of Occurrence of Cmax (Tmax) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Tmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Measured: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Apparent Clearance Following Oral Dosing (CL/F) Following Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of CL/F following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Measured: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Terminal Absorption Elimination Half-life (t1/2) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of t1/2 following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Measured: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Apparent Terminal Phase Rate Constant (Lambda z) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Lambda z following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Measured: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Volume of Distribution at Steady State (Vss) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Blood samples were collected at the indicated time points for the determination of Vss following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Measured: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Ctau Following IM Dosing With CAB LA During Injection Phase
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
AUC(0-tau) Following IM Dosing With CAB LA During Injection Phase
Blood samples were collected at the indicated time points for the determination of AUC (0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Cmax Following IM Dosing With CAB LA During Injection Phase
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Tmax Following IM Dosing With CAB LA During Injection Phase
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41

Secondary outcomes (18)

Ctau Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
AUC(0-tau) Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Cmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Tmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 7 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
CL/F Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of CL/F following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 7, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
T1/2 Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of t1/2 following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Lambda z Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Lambda z following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Vss Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Blood samples were collected at the indicated time points for the determination of Vss following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Measured: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Number of Participants With Non-serious AEs and SAEs (Oral lead-in Phase)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity, Is a congenital anomaly/birth defect, other situation as per investigator's judgement.
Measured: Up to Week 4
Number of Participants Withdrawn Due to AEs-oral lead-in Phase
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
Measured: Up to Week 4
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included ALT, albumin, ALP, AST, bilirubin, calcium (hypercalcemia and hypocalcemia), CO2 decreased, cholesterol, CPK increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Measured: Up to Week 4
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Hematology parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: APTT prolonged, Hb (increased), WBC (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Measured: Up to Week 4
Number of Participants With Abnormal Urinalysis Parameters: Oral lead-in Phase
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Measured: Up to Week 4
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: SBP (Low <85 mmHg, High: >160 mmHg), DBP (Low: <45 mmHg, High: >100 mmHg), pulse rate (Low: <40 mmHg, High: >100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Measured: Up to Week 4
Percentage of Participants With Injection Discontinuation-Injection Phase
Percentage of participants with injection discontinuation is presented.
Measured: Week 5 to 41
Number of Participants With Grade 2 to 4 Injection Site Pain-Injection Phase
Severity of injection site reactions was analyzed using DAIDS AE Grading Table. The severity is categorized into grades as following: Grade 1 (mild): causing no or minimal interference with usual social and functional activities, Grade 2 (moderate): causing greater than minimal interference with usual social and functional activities, Grade 3 (severe): causing inability to perform usual social and functional activities, Grade 4 (Potentially life threatening): causing inability to perform basic self-care functions or hospitalization indicated. Higher grade indicates more severe condition. Number of participants who had at least one Grade 2 to 4 Injection site reaction is presented.
Measured: Week 5 to 41
HIV-Prevention Treatment Satisfaction Total Score-Injection Phase
HIV-Prevention Treatment Satisfaction Questionnaire (change) (HIV-PrevTSQc) was used to assess participant tolerability and satisfaction to the treatment. It consisted total 13 questions. The experience of HIV prevention treatment was assessed using a scale from 3 (much more satisfied/effective/convenient/ flexible/likely to recommend the treatment/likely to speak well of the treatment/easier now) to -3 (much less satisfied/effective/convenient/flexible/likely to recommend the treatment/likely to speak well of the treatment/easier now). Total score was calculated by taking sum of scores of all questions. It ranges from -39 to 39, with higher scores indicating more satisfaction.
Measured: At Week 10
Number of Participants With Acceptability of Cabotegravir for HIV Prevention
Number of participants who consider using cabotegravir for HIV prevention in the future is presented. Participants were asked if they would consider using cabotegravir for HIV prevention in the future and their answers to this question were recorded as 'Yes', 'No' or 'Missing'.
Measured: Up to Week 41

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201820 Apr 2020

First posted5 Feb 2018
Study start10 Apr 2018
Primary completion20 Apr 2020
Study completion20 Apr 2020

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: Not applicable
Intervention model: Single group
Model description: Eligible subjects will receive oral doses of CAB for 4 weeks followed by IM dosing with CAB LA at Week 5, Week 9, Week 17, Week 25 and Week 33.
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03422172
Sponsor's protocol ID: 206898
Status last verified: May 2021
First submitted: 30 Jan 2018
Last updated: 13 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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, Wannamaker P, Lu H, Zhu B, Wang M, Paff M, Spreen WR, Ford SL. Safety, Tolerability, Pharmacokinetics, and Acceptability of Oral and Long-Acting Cabotegravir in HIV-Negative Chinese Men. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0205721. doi: 10.1128/AAC.02057-21. Epub 2022 Feb 7.
PubMed 35129374

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Phase 1 Study to Evaluate the PK, Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, Cabotegravir (CAB; GSK1265744) in HIV Uninfected Chinese Men
ClinicalTrials.gov ID: NCT03422172
Acronym / sponsor ID: 206898
Conditions: HIV Infections
Keywords: GSK1265744, Pre-Exposure Prophylaxis, Human immunodeficiency virus, Cabotegravir, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: PPD Development, LP
Study start: 10 Apr 2018 (actual)
Primary completion: 20 Apr 2020 (actual)
Study completion: 20 Apr 2020 (actual)
First posted: 5 Feb 2018 (actual)
Results: Posted 13 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Eligible subjects will receive oral doses of CAB for 4 weeks followed by IM dosing with CAB LA at Week 5, Week 9, Week 17, Week 25 and Week 33.

Arm	Type	Receives
Subjects receiving CAB	Experimental	Drug: Oral CAB, Drug: CAB LAEligible subjects will receive oral doses of CAB 30 milligrams (mg) tablets once daily for 4 weeks followed by IM injectable suspension of CAB LA 600 mg at Week 5, Week 9, Week 17, Week 25 and Week 33. There will be an approximately 1-week washout period between the last oral dose and the first injection of CAB at Week 5.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
Subjects are male at birth.
Subjects who have non-reactive point of care (POC) HIV test and undetectable HIV-1 ribose nucleic acid (RNA) at screening.
At risk of acquiring HIV, defined as having at least one casual male or female sex partner in the past 24 months.
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening.

Key exclusion criteria (16 listed)

Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia.
Active skin disease or disorder (that is [i.e.], infection, inflammation, dermatitis, eczema, drug rash, psoriasis, urticaria). Mild cases of localized acne or folliculitis or other mild skin condition may not be exclusionary at the discretion of the Investigator of Record or Medical Monitor.
Subjects determined by the Investigator to have a high risk of seizures, including subjects with an unstable or poorly controlled seizure disorder. A subject with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment.
Any medical condition, including psychiatric conditions that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.

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
Oral CABCAB tablet will be formulated as white to almost white, oval shaped, film coated 30 mg tablets, administered orally once daily. The CAB tablets will be packaged in bottles containing 30 tablets each.	Drug	Subjects receiving CAB
CAB LACAB LA is a sterile white to slightly colored suspension containing 200 mg/mL of CAB as free acid for administration by IM injection in gluteus medius.	Drug	Subjects receiving CAB

Primary outcome

Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs): Injection Phase
Time frame: Week 5 to 41
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, or other situations as per investigator's judgement.
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase
Time frame: Week 5 to 41
Hematology parameters were graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical hematology parameters included: Activated partial thromboplastin time (APTT) prolonged, hemoglobin (Hb) (increased), white blood cells (WBC) (decreased), lymphocytes count (decreased), neutrophils (decreased), platelets (decreased), prothrombin international normalized ratio (Pro.INR) (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase
Time frame: Week 5 to 41
Chemistry parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Higher grade indicates more severity. Clinical chemistry laboratory parameters included alanine amino transferase (ALT), albumin, alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), bilirubin, calcium (hypercalcemia and hypocalcemia), carbon dioxide (CO2) (decreased), cholesterol (high), Creatine phosphokinase (CPK) increased, Creatinine increased, creatinine clearance (decreased), glucose (hyperglycemia and hypoglycemia), Hypophosphatemia, Potassium (Hyperkalemia and hypokalemia), Sodium (hypernatremia and hyponatremia), Hypertriglyceridemia, uric acid (increased). Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase
Time frame: Week 5 to 41
Urinalysis parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as Grade 0: none, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Urinalysis parameters included: Protein. Baseline was the last available assessment prior to the time of the first dose. Maximum toxicity grade reached by a participant post-Baseline was summarized.
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Injection Phase
Time frame: Week 5 to 41
Vital signs were measured after participants had rested in supine position for at least 5 minutes. Clinical concern ranges were: systolic blood pressure (SBP) (Low: <85 millimeters of mercury [mmHg], High: >160 mmHg), diastolic blood pressure (DBP) (Low: <45 mmHg, High: >100 mmHg), pulse rate (Low: <40 mmHg, High: >100 mmHg). Worst case results are presented. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Number of Participants Withdrawn Due to AEs- Injection Phase
Time frame: Week 5 to 41
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants withdrawn from study due to AEs is presented.
Number of Participants Experiencing Injection Site Reactions (ISR)-Injection Phase
Time frame: Week 5 to 41
Injection site reactions were recorded via ISR diaries and managed through investigator assessment. Number of participants who experienced any injection site reaction (like pain, itching, bruising, bump, discoloration, redness, skin firmness, swelling, warm to touch etc.) is presented.
Concentration of Cabotegravir in Plasma at the End of the Dosing Interval (Ctau)-Oral lead-in Phase
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Blood samples were collected at the indicated time points for the determination of Ctau following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Dosing of Cabotegravir-Oral lead-in Phase
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Blood samples were collected at the indicated time points for the determination of AUC(0-tau) following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Maximum Observed Concentration (Cmax) Following Oral Dosing With Cabogegravir-Oral lead-in Phase
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Blood samples were collected at the indicated time points for the determination of Cmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Time of Occurrence of Cmax (Tmax) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Blood samples were collected at the indicated time points for the determination of Tmax following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Apparent Clearance Following Oral Dosing (CL/F) Following Dosing With Cabotegravir-Oral lead-in Phase
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Blood samples were collected at the indicated time points for the determination of CL/F following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Terminal Absorption Elimination Half-life (t1/2) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Blood samples were collected at the indicated time points for the determination of t1/2 following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Apparent Terminal Phase Rate Constant (Lambda z) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Blood samples were collected at the indicated time points for the determination of Lambda z following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Volume of Distribution at Steady State (Vss) Following Oral Dosing With Cabotegravir-Oral lead-in Phase
Time frame: Day 27: Pre-dose and at 1, 2, 3, 4, 8, 24 and 168 hours post-dose
Blood samples were collected at the indicated time points for the determination of Vss following oral dose of Cabotegravir and was calculated by standard non-compartmental analysis.
Ctau Following IM Dosing With CAB LA During Injection Phase
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Blood samples were collected at the indicated time points for the determination of Ctau following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
AUC(0-tau) Following IM Dosing With CAB LA During Injection Phase
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Blood samples were collected at the indicated time points for the determination of AUC (0-tau) following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Cmax Following IM Dosing With CAB LA During Injection Phase
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Blood samples were collected at the indicated time points for the determination of Cmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.
Tmax Following IM Dosing With CAB LA During Injection Phase
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41
Blood samples were collected at the indicated time points for the determination of Tmax following IM dose of CAB LA and was calculated by standard non-compartmental analysis.

18 secondary outcomes

Ctau Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
AUC(0-tau) Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Cmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Tmax Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Time frame: Pre-dose sample on Weeks 7 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
CL/F Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Time frame: Pre-dose sample on Weeks 7, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
T1/2 Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Lambda z Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Vss Following IM Dosing With CAB LA Through Injection and Long-term Follow-up Phases
Time frame: Pre-dose sample on Weeks 5, 9, 17, 25, 33; Post-dose sample on Weeks 6, 10, 18, 26, 34, 37, 41, 53, 65, 77, 89
Number of Participants With Non-serious AEs and SAEs (Oral lead-in Phase)
Time frame: Up to Week 4
Number of Participants Withdrawn Due to AEs-oral lead-in Phase
Time frame: Up to Week 4
Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Oral lead-in Phase
Time frame: Up to Week 4
Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters: Oral lead-in Phase
Time frame: Up to Week 4
Number of Participants With Abnormal Urinalysis Parameters: Oral lead-in Phase
Time frame: Up to Week 4
Number of Participants With Shift From Baseline in Vital Signs With Respect to Clinical Concern Range: Oral lead-in Phase
Time frame: Up to Week 4
Percentage of Participants With Injection Discontinuation-Injection Phase
Time frame: Week 5 to 41
Number of Participants With Grade 2 to 4 Injection Site Pain-Injection Phase
Time frame: Week 5 to 41
HIV-Prevention Treatment Satisfaction Total Score-Injection Phase
Time frame: At Week 10
Number of Participants With Acceptability of Cabotegravir for HIV Prevention
Time frame: Up to Week 41

Results and safety

Results posted to the registry on 13 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cabotegravir	48	47

Primary outcome: Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs): Injection Phase

Time frame: Week 5 to 41. Count of participants. Unit: Participants

Measure	CAB LA 600 mg (Injection Phase) n = 47
Non-serious AEs	47
SAEs	1

Population analysed: Safety Injection Population. It comprised of all participants who received at least one CAB LA injection.

Primary outcome: Number of Participants With Maximum Toxicity Post-Baseline in Hematology Parameters-Injection Phase

Time frame: Week 5 to 41. Count of participants. Unit: Participants

Measure	CAB LA 600 mg (Injection Phase) n = 47
APTT prolonged, Grade 0, n=28	28
APTT prolonged, Grade 1, n=28	0
APTT prolonged, Grade 2, n=28	0
APTT prolonged, Grade 3, n=28	0
APTT prolonged, Grade 4, n=28	0
Hb (increased), Grade 0, n=47	47
Hb (increased), Grade 1, n=47	0
Hb (increased), Grade 2, n=47	0

Population analysed: Safety Injection Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category title).

Primary outcome: Number of Participants With Maximum Toxicity Post-Baseline in Chemistry Parameters: Injection Phase

Time frame: Week 5 to 41. Count of participants. Unit: Participants

Measure	CAB LA 600 mg (Injection Phase) n = 47
ALT, Grade 0, n=47	41
ALT, Grade 1, n=47	6
ALT, Grade 2, n=47	0
ALT, Grade 3, n=47	0
ALT, Grade 4, n=47	0
Albumin, Grade 0, n=47	47
Albumin, Grade 1, n=47	0
Albumin, Grade 2, n=47	0

Population analysed: Safety Injection Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category title).

Primary outcome: Number of Participants With Maximum Toxicity Post-Baseline in Urinalysis Parameters: Injection Phase

Time frame: Week 5 to 41. Count of participants. Unit: Participants

Measure	CAB LA 600 mg (Injection Phase) n = 29
Protein, Grade 0	29
Protein, Grade 1	0
Protein, Grade 2	0
Protein, Grade 3	0
Protein, Grade 4	0

Population analysed: Safety Injection Population. Only those participants with data available at the specified time points were analyzed.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious AEs and SAEs were collected up to Week 4 for oral-lead in phase; Weeks 5 to 41 for Injection phase and Weeks 42 to 89 for long-term follow-up phase.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CAB 30 mg - Oral lead-in Phase	0 of 48 (0%)	13 of 48 (27.1%)	0 of 48
CAB LA 600 mg - Injection Phase	1 of 47 (2.1%)	47 of 47 (100%)	0 of 47
CAB LA 600 mg - Long-term Follow-up Phase	0 of 47 (0%)	17 of 47 (36.2%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35129374Han K, Wannamaker P, Lu H, Zhu B, Wang M, Paff M, Spreen WR, Ford SL. Safety, Tolerability, Pharmacokinetics, and Acceptability of Oral and Long-Acting Cabotegravir in HIV-Negative Chinese Men. Antimicrob Agents Chemother. 2022 Mar 15;66(3):e0205721. doi: 10.1128/AAC.02057-21. Epub 2022 Feb 7.
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

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 Oral CAB and CAB LA in people with HIV Infections, run by ViiV Healthcare at 3 sites in China.

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 16 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 13 May 2021. 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 China. 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 13 May 2021). 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?

Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs): Injection Phase (time frame: Week 5 to 41). The study lists 19 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 NCT03422172, 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 13 May 2021.