NCT04233047

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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/

Detailed description

Fostemsavir (FTR) is the prodrug of temsavir (TMR), which is a novel, first-in-class attachment inhibitor being developed as a potential treatment of HIV-1 infection. Investigational FTR is being made available on a compassionate use named patient basis for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are experiencing virologic failure (confirmed HIV-1 RNA ≥1000 c/mL) and are unable to comprise a suppressive regimen with currently available antiretrovirals. Such patients, who are often heavily treatment experienced (HTE), represent a small and highly vulnerable subgroup within the overall HIV patient population. The care of HTE patients is difficult and often complicated by the presence of complex comorbidities, extensive concomitant medication profiles, and advanced HIV disease.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Fostemsavir	Fostemsavir 600 mg extended release tablets, administered 600 mg twice daily, will be supplied for compassionate use for the identified individual patient.

Timeline

• First posted: 2020-01-18
• Last updated: 2025-05-13