Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorViiV Healthcare

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

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators