A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

Completed · Phase 3

Conditions studied: HIV Infections

In brief

This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

Key facts

Study ID

NCT04542070

Run by

ViiV Healthcare

People needed

687

Starts

2020-11-09

Expected to finish

2023-04-17

Last updated by the study team

2024-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants aged 18 years or older (or >=19 where required by local regulatory agencies), at the time of signing the informed consent.
• A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), 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, 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.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Eligible participants or their legal guardians (and next of kin when locally required), must sign a written Informed Consent Form before any protocol-specified assessments are conducted. Enrollment of participants who are unable to provide direct informed consent is optional and will be based on local legal/regulatory requirements and site feasibility to conduct protocol procedures.
• Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
• Must be on the uninterrupted current regimen of BIK for at least 6 months prior to Screening with an undetectable HIV-1 viral load for at least 6 months prior to Screening. BIK must be the participant's first or second regimen. If BIK is the second regimen, the first regimen must be an integrase inhibitor (INI) regimen. Only a single prior Integrase inhibitor (INI) regimen is allowed if BIK is a second line regimen >=6 months prior to screening. Any history of non-integrase strand transfer inhibitor regimens (that is. non-nucleoside reverse transcriptase inhibitor, protease inhibitor, C-C chemokine receptor 5 and other entry inhibitors) are not permitted. Any prior change in regimen, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must not have been done for treatment failure (HIV-1 RNA >=400 c/mL).
• The following are limited exceptions:
• A change from Tenofovir disoproxil fumarate (TDF) to TAF will not be considered a regimen change.
• Historical perinatal use of Nucleoside reverse transcriptase inhibitor (NRTI) when given in addition to an ongoing Highly active antiretroviral therapy (HAART) will not be considered a change in ART therapy regimen.
• The past use of ARVs in the context of Post Exposure Prophylaxis (PEP) or Pre-Exposure Prophylaxis (PrEP) while the participant was HIV negative will be allowed. Such cases will be evaluated on a case by case basis with the Medical Monitor, and may require documentation of HIV negative serology during time of PEP or PrEP.
• A change in dosing scheme of the same drug from twice daily to once daily will not be considered a change in ART regimen if data support similar exposures and efficacy.
• A change in formulation from multiple class regimens to single treatment regimens (of the same medications) would not be considered a change in ART regimen.
• Documented evidence of plasma HIV-1 RNA measurements <50 c/mL in the 6 months prior to Screening.
• Plasma HIV-1 RNA <50 c/mL at Screening.

You may not qualify if…

• Within 6 months prior to Screening, any plasma HIV-1 RNA measurement >=50 c/mL.
• Within the 6 to 12-month window prior to Screening, documented evidence of any plasma HIV-1 RNA measurement greater than (>)200 c/mL, or 2 or more plasma HIV-1 RNA measurements >=50 c/mL.
• History of prior treatment failure to any Department of Health and Human Services (DHHS) recommended ART regimen.
• History of drug holiday >1 month for any reason prior to Screening visit, except where all ART was stopped due to tolerability and/or safety concerns.
• Any change to a second line regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV 1 RNA measurement >=200 c/mL after initial suppression to <50 c/mL while on first line HIV therapy regimen).
• Participants who are currently participating in or anticipate being selected for any other interventional study.
• Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.
• Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy, and CD4+ counts <200 cells/microliter are not exclusionary.
• Participants with moderate to severe hepatic impairment.
• Any pre-existing physical or mental condition (including substance use 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.
• All participants will be screened for syphilis.
• Participants with untreated secondary (late latent) or tertiary syphilis infection, defined as a positive rapid plasma reagin (RPR) and a positive treponemal test without clear documentation of treatment, are excluded.
• Participants with a false positive RPR (with negative treponemal test) or serofast RPR result (persistence of a reactive nontreponemal syphilis test despite history of adequate therapy and no evidence of re-exposure) may enroll after consultation with the Medical Monitor.
• Participants with primary syphilis or early latent secondary syphilis (acquired within the preceding year) who have a positive RPR test and have not been treated may be treated during the screening period and if completion of antibiotic treatment occurs during the screening period, may be allowed entry after consultation with the Medical Monitor. If antibiotic treatment cannot be completed before the screening window ends, participants may be rescreened once following completion of antibiotic therapy for primary or early latent secondary syphilis.
• Participants who, in the investigator's judgment, pose 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, gluteal implant/enhancements 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), whether negative or 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 require or qualify for immediate HCV treatment are excluded for those co-infected participants who post entry into Switch Onto Long Acting Regimen (SOLAR) decide treatment for HCV infection is warranted or desired either by the participant or by the treating physician.
• Participants with HCV co-infection will be allowed entry into this study if:
• Liver enzymes meet entry criteria
• HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the Month 14 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 inconclusive, the fibrosis (Fib)-4 score will be used to verify eligibility

Where it is running

• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Palm Springs, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — Ft. Pierce, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Pensacola, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Kansas City, Kansas, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Southfield, Michigan, United States
• GSK Investigational Site — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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