Fostemsavir trometamol for HIV-1 infection

Inclusion criteria

• {"criterion_text":"- HIV-1 infected adult Age > 18 years (non-childbearing potential or agrees to highly effective contraception methods)\n- On stable & suppressive cART with a VL ≤50 c/mL for 1 year allowing one blip (50-200 c/mL) as long as resuppressed below 50 for 6 consecutive months prior to enrolment and with no major adherence issues.\n- Patients on bPI with no other potential switch to another approved regimen (except to ibalizumab and/or lenacapavir, if available) due to intolerance to prior therapy or resistance.\n- No significant laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators.\n- Willing to sign an informed consent and take part in the trial."}

Exclusion criteria

• {"criterion_text":"- Age < 18 years\n- Unable to take part in the trial according to the investigator opinion (example: unable to understand the trial information leaflet, unable to provide written consent, etc.)\n- History of being on a cART containing Fostemsavir.\n- HIV-1 subtype AE\n- Use of medications that are known to interact with Fostemsavir. Contraindications are given in appendix 3, and full information on drug-drug interactions is given in SmPC.\n- Hypersensitivity to active substance or excipient of Fostemsavir as listed in SmPC.\n- Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical or anal intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Trial medical monitor for inclusion of the patient prior to trial entry\n- Known acute or chronic viral hepatitis including, but not limited to, A, B, or C. Chronic hepatitis B and history of hepatitis C (cured) are allowed.\n- Any investigational drug within 30 days prior to the trial drug administration\n- Unable to take oral medications\n- IOCBP who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the trial\n- Patients with severe hepatic impairment (Class C) as determined by Child-Pugh classification\n- Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophagael or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)\n- History of congestive heart failure or congenital prolonged QT syndrome.\n- Confirmed QT value > 500 msec at Screening or Day 1\n- Confirmed QTcF value > 470 msec for women and > 450 msec for men at Screening or Day 1\n- ALT>5 times the ULN, OR ALT>3xULN and bilirubin>1.5xULN (with >35% direct bilirubin).\n- Any other condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial."}

Primary endpoints

• {"endpoint_text":"- To assess the proportion of patients with confirmed HIV viral load ≥50 copies/mL at week 48","definition_or_measurement_approach":"Proportion of patients with confirmed HIV viral load ≥50 copies/mL at week 48"}

Secondary endpoints

• {"endpoint_text":"- Rates of individuals with VL < 50 copies/mL at week 24 (FDA Snapshot algorithm)","definition_or_measurement_approach":"Measured using FDA Snapshot algorithm at week 24"}
• {"endpoint_text":"- Rates of individuals with VL < 50 copies/mL at week 48 (FDA Snapshot algorithm)","definition_or_measurement_approach":"Measured using FDA Snapshot algorithm at week 48"}
• {"endpoint_text":"- Rates of individuals with VL < 200 copies/mL at week 24 (FDA Snapshot algorithm)","definition_or_measurement_approach":"Measured using FDA Snapshot algorithm at week 24"}
• {"endpoint_text":"- Rates of individuals with VL < 200 copies/mL at week 48 (FDA Snapshot algorithm)","definition_or_measurement_approach":"Measured using FDA Snapshot algorithm at week 48"}
• {"endpoint_text":"- CD4 count, CD4:CD8 ratio and Lymphocyte subsets (CD4 and CD8) at week 48.","definition_or_measurement_approach":"Laboratory measurement of CD4, CD8 counts and CD4:CD8 ratio at week 48"}
• {"endpoint_text":"- To evaluate the potential for drug-drug interactions in those who switch from their cART to Fostemsavir based on the University of Liverpool Drug interaction website or other sources of drug interaction knowledge, including prescribed drugs, hormones, over-the-counter medications and recreational drugs.","definition_or_measurement_approach":"Evaluation based on University of Liverpool Drug interaction website or other drug interaction knowledge sources; assessment of concomitant medications"}
• {"endpoint_text":"- Occurrence of adverse events, severity of adverse events and occurrence of treatment discontinuations due to tolerability of treatment.","definition_or_measurement_approach":"Collection and grading of adverse events and recording of treatment discontinuations"}
• {"endpoint_text":"- Safety and tolerability of Fostemsavir in the studied population, including lipids, glucose, insulin resistance (HOMA-IR) and weight, change in waist circumference.","definition_or_measurement_approach":"Clinical/laboratory measurements of lipids, glucose, HOMA-IR, weight and waist circumference"}
• {"endpoint_text":"- Patient reported benefits of switching. To describe changes in the quality of life and perception of health (patient reported outcomes will be collected following the administration of specific questionnaires (including wellness thermometer, PHQ9, and GAD-7) in relation to the drug switch).","definition_or_measurement_approach":"Patient-reported outcome questionnaires including wellness thermometer, PHQ-9, GAD-7"}
• {"endpoint_text":"- To assess change from baseline in clinical outcomes (e.g., bone health by FRAX, kidney function; cardiovascular risk, weight, BMI, and waist circumference by equation calculation). Data will be collected from routine care clinical records.","definition_or_measurement_approach":"Change from baseline in clinical outcomes collected from routine care records (FRAX for bone health, kidney function tests, cardiovascular risk calculations, anthropometrics)"}

Italy

Earliest CTIS Part Ii Submission Date

03-11-2023

Latest Decision Or Authorization Date

25-01-2024

Processing Time Days

83

Number Of Sites

3

Number Of Participants

20

Spain

Earliest CTIS Part Ii Submission Date

03-02-2025

Latest Decision Or Authorization Date

10-03-2025

Processing Time Days

35

Number Of Sites

5

Number Of Participants

25

Primary sponsor

Full Name

NEAT ID Foundation

Organisation Type

Patient organisation/association

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"ViiV Healthcare UK Ltd.","duties_or_roles":"Monetary support","organisation_type":""}