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Evaluating efficacy and safety of switching a boosted protease inhibitor to fostemsavir in PLWH with limited therapeutic options (FOST Switch)
EU CTIS ID: 2023-504192-25-00
What this study is testing
To assess the proportion of patients with HIV viral load ≥ 50 copies/mL at week 48.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- HIV-1 infected adult Age > 18 years (non-childbearing potential or agrees to highly effective contraception methods)
- 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.
- 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.
- No significant laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators.
- Willing to sign an informed consent and take part in the trial.
You likely can't join if
- Age < 18 years
- 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.)
- History of being on a cART containing Fostemsavir.
- HIV-1 subtype AE
- 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.
- Hypersensitivity to active substance or excipient of Fostemsavir as listed in SmPC.
See the full eligibility criteria
- HIV-1 infected adult Age > 18 years (non-childbearing potential or agrees to highly effective contraception methods)
- 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.
- 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.
- No significant laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators.
- Willing to sign an informed consent and take part in the trial.
- Age < 18 years
- 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.)
- History of being on a cART containing Fostemsavir.
- HIV-1 subtype AE
- 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.
- Hypersensitivity to active substance or excipient of Fostemsavir as listed in SmPC.
- 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
- 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.
- Any investigational drug within 30 days prior to the trial drug administration
- Unable to take oral medications
- IOCBP who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the trial
- Patients with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- 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)
- History of congestive heart failure or congenital prolonged QT syndrome.
- Confirmed QT value > 500 msec at Screening or Day 1
- Confirmed QTcF value > 470 msec for women and > 450 msec for men at Screening or Day 1
- ALT>5 times the ULN, OR ALT>3xULN and bilirubin>1.5xULN (with >35% direct bilirubin).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.