Human Immunological virus HIV-1 patients currently virologically supressed and being treated with with boosted protease inhibitors Infections and Infestations
Conditions
Interventions
FOST Switch is a proof of concept, prospective, non-randomised, single-arm, multi-centre trial that will enrol 60 patients, and each patient will act as their own control.
Trial participants include
Sponsors
NEAT ID
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected adults 2. Non-pregnant Individuals of Childbearing potential (IOCBP) must be confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and a negative urine hCG test at Day 1 and each visit). 3. IOCBP should be receiving highly effective contraception. 4. On stable & suppressive cART with a VL <50 c/mL for 1 year allows 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. 5. Patients on bPI with no other potential switch to another approved regimen (except to Ibilizimuab if available) and are willing to switch to Fostemsavir from their boosted PI. 6. No significant laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators. 7. Willing to sign an informed consent and take part in the trial.
Exclusion criteria
Exclusion criteria: 1. Age 500 msec at Screening or Day 1. 15. Confirmed QTcF value > 470 msec for women and > 450 msec for men at Screening or Day 1 16. ALT>5 times the ULN, OR ALT>3xULN and bilirubin>1.5xULN (with >35% direct bilirubin). 17. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the proportion of patients with confirmed HIV viral load =50 copies/mL at week 48. Confirmed VL is defined as two consecutive VL measurements confirmed to be = 50 copies/mL. Patients should return within 2-4 weeks for a confirmatory VL. | — |
Secondary
| Measure | Time frame |
|---|---|
| At week 48 unless the individual endpoint states week 24: 1. Rates of individuals with VL < 50 copies/mL at week 24 (FDA Snapshot algorithm) 2. Rates of individuals with VL < 50 copies/mL at week 48 (FDA Snapshot algorithm) 3. Rates of individuals with VL < 200 copies/mL at week 24 (FDA Snapshot algorithm) 4. Rates of individuals with VL < 200 copies/mL at week 48 (FDA Snapshot algorithm) 5. CD4 count and Lymphocyte subsets (CD4 and CD8) at week 48. 6. 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. The number of potential DDIs must be avoided. This will be measured by comparing the drug interaction outcomes between antiretroviral therapy and co-medications before and after the switch by using the www.hiv-druginteractions.org/ website (within the same trial arm and between trial arms). The grading will be done by looking at how many amber or red interactions will be graded green after the switch. For example, if a patient is on Atorvastatin as a co-medication and on two NRTIs and Darunavir/Cobicistat he would score “one amber and two green”, and when switched to Rilpivirine/Dolutegravir, he would score “all green”, showing the latter regimen is more favourable in terms of drug-drug interactions). 7. Occurrence of adverse events, severity of adverse events and occurrence of treatment discontinuations due to tolerability of treatment. 8. Safety and tolerability of Fostemsavir in the studied population, including lipids, glucose, insulin resistance (HOMA-IR) and weight, change in waist circumference. 9. 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 (includi | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed