Comparing hospital and home treatment for HIV with long-acting drugs
Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study
This study is testing whether people with HIV feel better and manage their treatment more easily when they receive long-acting medications at home compared to in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06468995 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, double-arm, randomized, open-label trial that evaluates the effectiveness and implementation of long-acting antiviral treatments for HIV-1-infected patients. Participants will receive either hospital-based or home-based administration of CAB LA and RPV LA, with the aim of identifying factors that affect the feasibility and acceptability of each treatment setting. The study will utilize various questionnaires to gather data from both patients and healthcare providers, focusing on real-world delivery of treatment in Milan, Italy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older living with HIV-1 who are virologically suppressed and willing to switch to long-acting therapy.
Not a fit: Patients with recent evidence of viral load above acceptable thresholds or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment adherence and patient satisfaction by identifying the most effective administration setting for long-acting HIV therapies.
How similar studies have performed: Previous studies have shown promise in the use of long-acting antiviral therapies for HIV, indicating that this approach is both viable and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- IRCCS San Raffaele Scientific Institute — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Silvia Nozza, MD — Vita-Salute San Raffaele University
- Study coordinator: Silvia Nozza, MD
- Email: nozza.silvia@hsr.it
- Phone: 0226437934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.