Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy - The RELAI Study

Prior treatment

• Use of concomitant medications with a known risk of Torsade de Pointes including: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, diopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozidine, probucol, procanimide, quinidine, sotalol, sparfloxacxin, terfenadine, thioridizine.
• Use of prohibited medications including anticonvulsants, anti-mycobacterials, or systemic dexamethasone.
• Prior evidence of chronic Hepatitis B virus (HBV) infection, defined as positive hepatitis B surface antigen OR positive hepatitis B core antibody and negative hepatitis B surface antibody prior to enrollment.
• Prior history of virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART regimen
• History of major resistance-associated mutation (RAM) to any non-nucleoside reverse transcriptase inhibitor (NNRTI) on prior HIV genotype testing according to International Antiviral Society (IAS) criteria.
• History of a major RAM to an integrase strand inhibitor (INSTI) on prior HIV genotype testing according to IAS criteria.
• Known or suspected NNRTI or INSTI resistance. NOTE: in the absence of genotype data, clinical judgement based on prior regimens and response will be applied to determine suspected resistance.
• Any serious illness requiring systemic treatment or hospitalization, the participant must either complete therapy or be clinically stable on therapy, in the opinion of the site investigator, for at least 90 days prior to enrollment.
• Use of any other investigational treatment within 6 months prior to enrollment.

Other illness

• Any past use of LA-CAB/RPV for HIV treatment.
• History of liver cirrhosis
• History of severe hepatic impairment (Child-Pugh Class C).
• Known allergic reactions to components of study treatment, specifically cabotegravir or rilpivirine.
• Any medical, psychiatric, substance abuse, occupational or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or assessment of safety.

Lab values

• History of estimated glomerular filtration rate (eGFR) \<30, determined by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation found at: https://www.mdcalc.com/calc/3939/ckd-epi-equations-glomerular-filtration-rate-gfr

Other

• Women who are pregnant or breastfeeding.
• Current incarceration.
• Inability to communicate effectively with study personnel.

• HIV-1 infection documented by at least one of the following at any time prior to study entry:
  • any licensed rapid HIV test
  • HIV antibody test
  • HIV Ag/Ab assay
  • HIV-1 antigen, plasma HIV-1 RNA viral assay
  • Care provider in the electronic medical record (EMR)
• Adult men or women ≥ 18 years of age.
• Able and willing to give written informed consent.
• Able and willing to stay in contact with study staff during the duration of the trial.
• Able and willing to provide adequate locator information.
• Able to communicate in English.
• Currently residing in North Carolina.
• Able and willing to comply with all study requirements through duration of the trial.
• Previously received HIV care at the UNC Infectious Disease clinic
• No documented receipt of HIV care including in person or telemedicine visits in the 9 months prior to screening.
• No reported receipt of Antiretroviral therapy (ART) from a provider outside of the UNC Infectious Diseases clinic in the 9 months prior to screening.
• Willing to accept field-based injections of LA-CAB/RPV.
• Women of childbearing potential must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) while taking study medications