Clinical Trials

MainTitle

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

This study has been available
Sponsor
ViiV Healthcare


Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT04233047

First received: January 13, 2020
Last updated: January 13, 2020
Last Verified: January 2020
History of Changes
Purpose

Purpose

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/

Condition Intervention
HIV Infections

Drug : Fostemsavir

Study Type: Expanded Access   What is Expanded Access?
Official Title: Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)

Further study details as provided by ViiV Healthcare:

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  

Criteria

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
      1. 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.
          4. Males who are sexually active with WOCBP must use condoms for the duration of treatment with fostemsavir and 60 hours after last dose. In addition, males must be willing to refrain from sperm donation during this time.
          5. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but must comply with the pregnancy testing schedule as outlined in inclusion criterion 5b.

          Physicians shall counsel WOCBP and males who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. At a minimum, contraceptive counselling should be provided at the time of consent.


      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)
          1. Patient has a prior history of poor adherence with multiple failed attempts of oral
          ART

        contacts and locations

        Contacts and Locations

        Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

        Please refer to this study by its ClinicalTrials.gov identifier: NCT04233047

        Contacts

        Contact:   US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
        Contact:   EU GSK Clinical Trials Call Center GSKClinicalSupportHD@gsk.com

        Sponsors and Collaborators

        ViiV Healthcare

        Investigators

        Study Director: GSK Clinical Trials ViiV Healthcare
        More Information

        More Information


        Responsible Party: ViiV Healthcare  
        ClinicalTrials.gov Identifier: NCT04233047   History of Changes  
        Other Study ID Numbers: 207214  
        Study First Received: January 13, 2020  
        Last Updated: January 13, 2020  

        Keywords provided by ViiV Healthcare:

        Human Immunodeficiency Virus 1 (HIV-1)

        Additional relevant MeSH terms:
        HIV Infections
        Acquired Immunodeficiency Syndrome
        Immunologic Deficiency Syndromes

        ClinicalTrials.gov processed this data on June 01, 2020
        This information is provided by ClinicalTrials.gov.