HIV InfectionsNCT04233047
Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)
A study testing Fostemsavir in people with HIV Infections, run by ViiV Healthcare.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Fostemsavir
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
- Patient is experiencing virologic failure (confirmed HIV-1 RNA ≥1000 c/mL) on a current antiretroviral therapy (ART) regimen and:
- is unable to comprise a suppressive regimen without fostemsavir due to documented multi-drug resistance test results and/or intolerance and/or contraindication AND
- 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
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- Patient meets the following reproductive status criteria:
- Women must not be breastfeeding
- 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.
- 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.
- 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.
- 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.
Who cannot join
- Patients will not be eligible for fostemsavir compassionate use if any of the following criteria apply:
- Patient is eligible to access commercial fostemsavir or investigational fostemsavir by means other than the named patient program.
- Patient is taking one or more prohibited medications including:
- 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 locations and contacts
No sites are listed yet.
About this study
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/
Read the 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
- Being tested
- Fostemsavir
- Keywords
- Human Immunodeficiency Virus 1 (HIV-1)
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FostemsavirDrug
Fostemsavir 600 mg extended release tablets, administered 600 mg twice daily, will be supplied for compassionate use for the identified individual patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233047
- Sponsor's protocol ID
- 207214
- Status last verified
- May 2025
- First submitted
- 13 Jan 2020
- Last updated
- 13 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)
- ClinicalTrials.gov ID
- NCT04233047
- Acronym / sponsor ID
- 207214
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency Virus 1 (HIV-1)
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Patient is experiencing virologic failure (confirmed HIV-1 RNA ≥1000 c/mL) on a current antiretroviral therapy (ART) regimen and:
- Patient meets the following reproductive status criteria:
Key exclusion criteria (6 listed)
- Patients will not be eligible for fostemsavir compassionate use if any of the following criteria apply:
- Patient is eligible to access commercial fostemsavir or investigational fostemsavir by means other than the named patient program.
- Patient is taking one or more prohibited medications including:
- Patient has a prior history of poor adherence with multiple failed attempts of oral ART
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FostemsavirFostemsavir 600 mg extended release tablets, administered 600 mg twice daily, will be supplied for compassionate use for the identified individual patient. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
Questions about this trial
What is this clinical trial studying?
A study testing Fostemsavir in people with HIV Infections, run by ViiV Healthcare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.