About this trial
Compassionate use access to fostemsavir (GSK3684934, formerly BMS-663068) for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are experiencing virologic failure and are unable to comprise a suppressive regimen with currently available antiretrovirals.
Direct inquires to the ViiV Compassionate Use Portal via https://viiv-cu-portal.idea-point.com/
Eligibility criteria
Qualifiers
Patient has given consent for treatment
Patient is male or non-pregnant female, age 18 years and older. NOTE: there may be allowance for a lower minimum age if dictated by local regulatory and/or legal requirements.
Patient has chronic HIV-1 infection and is heavily treatment experienced
is unable to comprise a suppressive regimen without fostemsavir due to documented multi-drug resistance test results and/or intolerance and/or contraindication AND
Disqualifiers
Patient is eligible to access commercial fostemsavir or investigational fostemsavir by means other than the named patient program.
strong CYP3A inducers including, but not limited to: carbamazepine, phenytoin (anticonvulsants), mitotane (antineoplastic), enzalutamide (androgen receptor inhibitor), rifampicin (antimycobacterial) and St John's wort (Hypericum perforatum, herbal supplement),
elbasvir/grazoprevir (hepatitis C direct acting antiviral)
Patient has a prior history of poor adherence with multiple failed attempts of oral ART
Trial design
Treatments tested in this trial
- Fostemsavir