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

NCT04233047•ViiV Healthcare

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has given consent for treatment
•2. 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.
•3. Patient has chronic HIV-1 infection and is heavily treatment experienced
•4. Patient is experiencing virologic failure (confirmed HIV-1 RNA ≥1000 c/mL) on a current antiretroviral therapy (ART) regimen and:
•1. is unable to comprise a suppressive regimen without fostemsavir due to documented multi-drug resistance test results and/or intolerance and/or contraindication AND
•2. has no more than 2 fully active ART agents (0, 1, or 2 ART agents) which can be paired with fostemsavir as part of a viable combination ART regimen
•5. Patient meets the following reproductive status criteria:
•1. Women must not be breastfeeding
•2. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of fostemsavir and must agree to periodic pregnancy testing (as per local standard of care) for the duration of treatment with fostemsavir.
•3. WOCBP must agree to use at least 1 method of effective contraception for the duration of treatment with fostemsavir and 60 hours after fostemsavir drug exposure. Males must inform their female partners who are WOCBP of the contraceptive requirements of the NPP to which they too are expected to adhere.
+3 more criteria

Exclusion Criteria

•Patients will not be eligible for fostemsavir compassionate use if any of the following criteria apply:
•1. Patient is eligible to access commercial fostemsavir or investigational fostemsavir by means other than the named patient program.
•2. Patient is taking one or more prohibited medications including:
•1. 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),
•2. elbasvir/grazoprevir (hepatitis C direct acting antiviral)
•3. Patient has a prior history of poor adherence with multiple failed attempts of oral ART

Key Dates

Last Updated

May 13, 2025

Conditions

HIV Infections

Interventions

Fostemsavir

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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