HIV care goes home: study tests convenience of Long-Acting shots
NCT ID NCT06468995
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving long-acting HIV injections at home is as practical and acceptable as giving them in the hospital. About 120 adults with well-controlled HIV will receive the shots either at home or in the hospital. Researchers will measure how easy and appropriate each setting feels for patients and healthcare providers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * People living with HIV-1 infection that could, according to clinical practice, switch current ART to IM CAB + RPV; * Aged 18 years or older at the time of signing the informed consent. * People willing to switch to long-acting therapy * on a stable (≥6 months) antiretroviral regimen and virologically suppressed (HIV-1 RNA \<50 copies/ml): * 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. * Ability to understand informed consent form and other relevant regulatory documents. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Within 6 months prior to Screening, any plasma HIV-1 RNA measurement \>=50 c/mL or within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA measurement \>200 c/mL, or 2 or more plasma HIV-1 RNA measurements \>=50 c/mL. * Present or past evidence of viral resistance to agents of the NNRTI or INI class or prior treatment failure with agents of NNRTI or INSTI class * Unwillingness or any condition that might prevent the completion of all surveys over study follow-up. * Any contraindication for CAB LA, RPV LA, oral Cabotegravir or Rilpivirine (see EU SmPC): * 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/mL 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 * 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 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 * Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. * Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Clinicians must carefully assess if therapy specific for HCV infection is required; participants who require or qualify for immediate HCV treatment are excluded * Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis, or decompensated cirrhosis (eg. ascites, encephalopathy, or variceal bleeding)), 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 * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical and anal intraepithelial neoplasia. * 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 sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. * Current platelet count\<100,000 x109/L. * Any evidence of primary resistance based on the presence of any major known Integrase inhibitor (INI) or Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance-associated mutation, except for K103N by any historical resistance test result. * Any verified Grade 4 laboratory abnormality at screening. * Subjects has estimated creatinine clearance \<50mL/minute per 1.73-meter square via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method * Alanine aminotransferase (ALT) \>=3 × Upper limit of normal (ULN) * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening * Use of medications which are associated with Torsade de Pointes.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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IRCCS San Raffaele Scientific Institute
Milan, 20127, Italy
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Other studies related to the condition(s) this trial covers.
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