AzTrials
AzTrials

Human Immunodeficiency Virus Type 1 (HIV-1)Phase 3NCT05896748

Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

A Phase 3 study testing Cabotegravir - Injectable Suspension (CAB LA) and Rilpivirine - Injectable Suspension (RPV LA) in people with Human Immunodeficiency Virus Type 1 (HIV-1), run by ViiV Healthcare at 30 sites in 6 countries.

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

This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cabotegravir - Injectable Suspension (CAB LA) and Rilpivirine - Injectable Suspension (RPV LA)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
30 sitesin 6 countries
Study dates
8 Nov 2022to 14 Sep 2023
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent (FLAIR and Sub-study specific informed consent)
  • Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 12 months while on the FLAIR study. Any disruptions in dosing during FLAIR must be discussed with the Medical Monitor for a final determination of eligibility into the sub-study.
  • Plasma HIV-1 RNA <50 c/mL at Sub-Study Screening.
  • History of Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) vaccination (or booster dosing) is allowed prior to sub study screening and will be allowed during the conduct of the sub-study as long as the vaccine (or boosters) are not administered within 14 days of virologic load (VL) assessments.
  • HIV-1 infected antiretroviral therapy (ART)-naive men or women aged 18 years or greater at the time of signing the informed consent.
  • HIV-1 infection as documented by Screening plasma HIV-1 RNA >=1000 cubic (c)/mL
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  • Antiretroviral-naive (less than or equal to (<=10) days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary
  • Female Participants: A female participant is eligible to participate if she is not pregnant at Screening and first day of Induction Phase (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies
  • Non-reproductive potential defined as:
  • Pre-menopausal females with one of the following:
  • Documented tubal ligation;
  • Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion;
  • Hysterectomy; Documented Bilateral Oophorectomy;
  • Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
  • Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA.
  • The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.
  • All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (example [e.g.,] male condom) and on the risk of HIV transmission to an uninfected partner.
  • In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • More than 1 plasma HIV-1 RNA measurement 50 c/mL to <200 c/mL (virologic blip) within 24 weeks prior to sub-study Screening visit that was investigated and found NOT to be associated with alternative causes including recent vaccinations received within 4 weeks of the viral blip or NOT associated with intercurrent illness that developed within 2-4 weeks of the viral blip.
  • All viral blips that occurred within 24 weeks prior to screening should be discussed with the Medical Monitor to assess whether such a participant can enroll into the sub-study.
  • Any Suspected Virologic Failure (HIV-RNA 200 c/mL) as defined during FLAIR study.
  • Participants planning to require oral bridging during participation in the FLAIR sub study.
  • The participant has a tattoo or any dermatological condition overlying the abdominal or gluteal regions which may interfere with interpretation of injection site reactions.
  • Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
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  • Any woman of childbearing potential who is pregnant at screening will be excluded from entering the sub-study.
  • Any women of childbearing potential who gets pregnant while on the sub-study will have to be withdrawn from the sub-study but will be allowed to transition back to the parent FLAIR study if a pregnancy specific Informed Consent Form (ICF) is signed, and commercial access is not available at the time of pregnancy
  • Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study.
  • Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current cluster of differentiation 4+ (CD4+) cell count <200 cells/ cubic millimeter (mm^3) are not exclusionary.
  • Participants with known moderate to severe hepatic impairment.
  • Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
  • Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment 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 enrollment.
  • Participant who, in the investigator's judgment, poses a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
  • The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
  • Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows:
  • Participants positive for HBsAg are excluded;
  • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
  • Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment prior to Week 48 of the Maintenance Phase must be excluded. HCV treatment on study may be permitted post Week 48, following consultation with the Medical Monitor. Participants with HCV co-infection will be allowed entry into Phase 3 studies if:
  • Liver enzymes meet entry criteria;
  • HCV Disease has undergone appropriate work-up, HCV is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on participants with HCV co-infection at screening should include results from any liver biopsy, fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
  • In the event that recent biopsy or imaging data is not available or is inconclusive, the Fib-4 score will be used to verify eligibility.
  • A Fib-4 score > 3.25 is exclusionary;
  • Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation. Fibrosis 4 Score Formula: (Age * AST)/ (Platelets * [square root of ALT]).
  • Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • History of liver cirrhosis with or without hepatitis viral co-infection.
  • Ongoing or clinically relevant pancreatitis.
  • All participants will be screened for syphilis (rapid plasma reagin [RPR]). Participants with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Participants with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis.
  • Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study Medical Monitor for inclusion of the participant prior to enrollment.
  • Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the participant unable to receive study medication.
  • History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled.
  • Current or anticipated need for chronic anti-coagulation.
  • ALT >=3 times upper limit normal (ULN).
  • Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
  • Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product (IP).
  • Treatment with any of the following agents within 28 days of Screening:
  • radiation therapy;
  • cytotoxic chemotherapeutic agents;
  • tuberculosis (TB) therapy, with the exception of treatment of latent TB with isoniazid;
  • Immunomodulators that alter immune responses (such as chronic systemic corticosteroids, interleukins, or interferons).
  • Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
  • Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of the first dose of IP.
  • Use of medications which are associated with Torsades de Pointes
  • Any evidence of primary resistance to non-nuclease reverse transcriptase inhibitors (NNRTIs) (except for K103N which is allowed), or any known resistance to Integrase inhibitors from historical resistance test results.
  • Participants who are human leukocyte antigen (HLA)-B*5701 positive and are unable to use an NRTI backbone that does not contain abacavir (participants who are HLA-B*5701 positive may be enrolled if they use a nuclease reverse transcriptase inhibitors (NRTI) backbone that does not contain abacavir; HLA-B*5701 positive participants may be excluded from the study if local provision of an alternate NRTI backbone is not possible).
  • Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening Phase to verify a result.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participant's participation in the study of an investigational compound.
  • Participant has estimated creatinine clearance <50 mL/minute (min)/1.73 meter square (m^2) via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Participants who are currently participating in or anticipate to be selected for any other interventional study.

Trial locations and contacts

30 sites in 6 countries.

30 sites in 6 countries

Spain16 sites

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Elche, 03203

  • GSK Investigational Site

    Ferrol, 15405

  • GSK Investigational Site

    Granada, 18016

  • GSK Investigational Site

    La Laguna-Tenerife, 38320

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Murcia, 30003

  • GSK Investigational Site

    Murcia, 30120

  • GSK Investigational Site

    Palma de Mallorca, 07198

  • GSK Investigational Site

    San Sebastián de los Reyes, 28702

  • GSK Investigational Site

    Santa Cruz de Tenerife, 38010

  • GSK Investigational Site

    Santander, 39008

Other trials in Spain

United States5 sites

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Bellaire, Texas, 77401

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Macon, Georgia, 31201

Other trials in United States

South Africa3 sites

  • GSK Investigational Site

    Bloemfontein, Free State, 9301

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Wentworth, KwaZulu-Natal, 4052

Other trials in South Africa

United Kingdom3 sites

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Leeds, LS1 3EX

  • GSK Investigational Site

    London, E1 1BB

Other trials in United Kingdom

Japan2 sites

  • GSK Investigational Site

    Osaka, 540-0006

  • GSK Investigational Site

    Tokyo, 162-8655

Other trials in Japan

Canada1 site

  • GSK Investigational Site

    Toronto, Ontario, M5G 1K2

Other trials in Canada

About this study

Official title: An Amendment to the FLAIR Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Maintenance of Virological Suppression and Patient Reported Outcomes for Participants Receiving Cabotegravir (CAB 200 mg/mL) and Rilpivirine (300 mg/mL) Long-Acting Injections Following Sub-cutaneous (SC) Administration in the Anterior Abdominal Wall SC Tissue Compared With Intramuscular (IM) Administration in the Gluteus Medius Muscle in Adult Participants Living With HIV-1 Infection in the FLAIR Study

This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle in adult participants living with HIV-1 infection in the FLAIR study (NCT02938520).

Being tested
Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA)
Keywords
Antiretroviral agent, Rilpivirine, Cabotegravir, FLAIR, Human immunodeficiency virus
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

  • Cabotegravir - Injectable Suspension (CAB LA)Drug

    It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection.

  • Rilpivirine - Injectable Suspension (RPV LA)Drug

    It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.

Study groups in NCT05896748
Study groupRoleWhat they receive
Cabotegravir Long Acting (CAB LA) 400 Milligrams (mg) + Rilpivirine Long Acting (RPV) LA 600 mgExperimentalParticipants received an intramuscular (IM) injection of CAB LA 400 mg and RPV LA 600 mg on week -4 during the Screening phase. Participants then received a sub-cutaneous (SC) injection of CAB LA 400 mg + RPV LA 600 mg on Day 1 of Week 1, Week 4 and Week 8 (once in every 4 weeks (Q4W)) for a total of 12 weeks during the SC abdominal Injection Phase. 4 weeks later, participants returned to the clinic for an IM gluteal injection (at Week 12) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W at Week 16.
Receives: Drug: Cabotegravir - Injectable Suspension (CAB LA); Drug: Rilpivirine - Injectable Suspension (RPV LA)

What is being measured

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

  1. Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA

    Blood samples were collected at indicated time points for PK analysis.

    Measured: At screening Week-4; Day 1, Week 4, Week 8 for SC injections; and Week 12 for Return to IM gluteal injection

  2. Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA

    Blood samples were collected at indicated time points for PK analysis.

    Measured: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12 for Return to IM gluteal injection

  3. Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA

    Blood samples were collected at indicated time points for PK analysis.

    Measured: At screening week -3; Week 1, Week 5, Week 9 for SC abdominal injections; and Week 13 for Return to IM gluteal injection

  4. Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA

    Blood samples were collected at indicated time points for PK analysis.

    Measured: At screening Week -3; Week 1, Week 5, Week 9 for SC abdominal injections; and Week 13 for Return to IM gluteal injection

  5. Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA

    Blood samples were collected at indicated time points for PK analysis.

    Measured: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12, for Return to IM gluteal injection

  6. AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA

    Blood samples were collected at indicated time points for PK analysis.

    Measured: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12 for Return to IM gluteal injection

Secondary outcomes (40)

  1. Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase

    Severity of ISRs was analyzed using division of acquired immunodeficiency syndrome (DAIDS) grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition.

    Measured: From Day 1 Up to Week 12

  2. Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AESI was analyzed using DAIDS grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. AESI assessed were Depression, Anxiety, Impact on creatinine, Hyperglycaemia.

    Measured: From Day 1 Up to Week 12

  3. Number of Participants Who Discontinue Treatment Due to ISRs and AESIs - SC Injection Phase

    Measured: From Day 1 Up to Week 12

  4. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From the Last IM Gluteal Injection in Screening Phase to the End of the SC Injection Phase

    SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs.

    Measured: From Week -4 Up to Week 12

  5. Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase

    Blood samples were collected as assessed by protocol, at specific time points for the analysis of clinical chemistry parameters. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  6. Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  7. Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  8. Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  9. Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  10. Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  11. Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides

    Measured: Baseline (screening Week -4), and CFB at Week 12

  12. Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count

    Blood samples were collected as assessed by protocol, at specific time points for the analysis of hematology parameters. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  13. Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  14. Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  15. Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  16. Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume

    Measured: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12

  17. Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase

    Measured: Baseline (Day 1) and at Weeks 4, 8, 12

  18. Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase

    Measured: Baseline (Day 1) and at Weeks 4, 8, 12

  19. Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) of >=200 c/mL - SC Injection Phase

    Plasma samples were collected for quantitative analysis of HIV-1 RNA. CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 c/mL after prior suppression to <200 c/mL.

    Measured: From Day 1 Up to Week 12

  20. Number of Participants With Treatment Emergent Phenotypic Resistance - SC Injection Phase

    Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with treatment emergent phenotypic resistance were reported.

    Measured: From Day 1 Up to Week 12

  21. Number of Participants With Treatment Emergent Genotypic Resistance - SC Injection Phase

    Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with treatment emergent genotypic resistance were reported.

    Measured: From Day 1 Up to Week 12

  22. Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase

    A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included the question regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: Week -3 (Baseline)

  23. Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase

    A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included the question regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: Day 1

  24. Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase

    A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included the questions regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: Week 9

  25. Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase

    A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included the questions regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: Week 13

  26. HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score -Screening/IM Gluteal Injection Phase

    HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.

    Measured: Week -3 (Baseline)

  27. HIVTSQs Total Score -SC Injection Phase

    HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.

    Measured: At Week 9

  28. HIVTSQs Total Score -Return to IM Gluteal Injection Phase

    HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.

    Measured: At Week 17

  29. Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase

    HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.

    Measured: Baseline (Week -3) and up to Week 9

  30. Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase

    HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.

    Measured: Baseline (Week -3) and up to Week 17

  31. Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase

    HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.

    Measured: Week 9 and Week 17

  32. HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase

    HIVTSQc is a 12-item questionnaire to measure treatment satisfaction in HIV participants. Individual items were rated as +3 (much more satisfied) to -3(much less satisfied). Higher the score, greater the improvement in satisfaction with each aspect of treatment and lower the score, greater the deterioration in satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on the following items:Item 1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item 5=convenience in finding treatment,Item 6=flexibility in finding treatment,Item 7=understanding HIV,Item 8=extent to which the treatment fits in with lifestyle,Item 9=recommendation of present treatment to someone else,Item 10=continuation with present form of treatment,Item 11=easy or difficult treatment,Item 12=amount of discomfort/pain involved with present form of treatment.

    Measured: From Week -4 up to Week 9

  33. HIVTSQc Total Score at Indicated Time Points -SC Injection Phase

    HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change.

    Measured: From Week -4 up to Week 9

  34. Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase

    The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: At Week -3 (Baseline)

  35. PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase

    The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: At Week 1 and Week 9

  36. PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase

    The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: At Week 13

  37. Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase

    The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: Change from Baseline (Week -3) at Week 1 and Week 9

  38. Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase

    The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).

    Measured: Change from Baseline (Week -3) at Week 13

  39. Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase

    A preference questionnaire was used to assess participant's preference for the subcutaneous injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Intramuscular Injections in the buttock, Subcutaneous Injections in the Abdomen and No preference.

    Measured: Up to Week 9

  40. Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase

    A preference questionnaire was used to assess participant's preference for the subcutaneous injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Intramuscular Injections in the buttock, Subcutaneous Injections in the Abdomen and No preference.

    Measured: Up to Week 17

Timeline

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

  1. First posted9 Jun 2023
  2. Study start8 Nov 2022
  3. Primary completion14 Sep 2023
  4. Study completion14 Sep 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05896748
Sponsor's protocol ID
201584-001
Status last verified
Oct 2024
First submitted
31 May 2023
Last updated
26 Nov 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cabotegravir - Injectable Suspension (CAB LA) and Rilpivirine - Injectable Suspension (RPV LA) in people with Human Immunodeficiency Virus Type 1 (HIV-1), run by ViiV Healthcare at 30 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 49 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Spain, United States, South Africa, United Kingdom, Japan and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Nov 2024). 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?

Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA (time frame: At screening Week-4; Day 1, Week 4, Week 8 for SC injections; and Week 12 for Return to IM gluteal injection). The study lists 6 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 NCT05896748.

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 26 Nov 2024.

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