Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance
NCT ID: NCT04648280
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2022-06-30
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fostemsavir
Fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class ARV resistance
Fostemsavir
fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class ARV resistance
Interventions
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Fostemsavir
fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class ARV resistance
Eligibility Criteria
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Inclusion Criteria
* Antiretroviral-experienced with documented historical or baseline resistance to one or more agents in at least two classes. All resistance has to be properly documented.
* Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 1000 c/mL (first value from Investigator within 6 months of screening visit, with the second value obtained from Screening labs, without a decline greater than 1 log10, and no value \<1000 in between).
* Documented resistance to at least one component of the current failing regimen per screening resistance testing.
* Must have at least 1 fully active and available agent in 2 or more ARV classes, based on current and/or documented historical resistance testing, taking into account tolerability, and other safety concerns. At least two fully active agents must be a part of the initial OBT to be paired with FTR.
* Girls who have reached menarche must have a negative pregnancy test at screening, not be breastfeeding, and be willing to adhere to effective methods of contraception if sexually active. All participants (male or female) have to agree with recommendations for effective contraception.
Exclusion Criteria
* Unable to comply with dosing requirements (to swallow solid pharmaceutical form of the investigational medicinal product)
* Unable to comply with study visits
* Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the participant unable to take oral medication.
* Any clinical condition (including but not limited to recreational drug use) or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study
* Pregnancy and breastfeeding
Physical and Laboratory Test Findings:
* Chronic untreated Hepatitis B virus (HBV) (however, participants with chronic treated HBV or spontaneously remitted HBV are eligible)
* HIV-2 infection
* Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN and bilirubin ≥1.5xULN (with\>35% direct bilirubin)
* History of unstable liver disease, decompensated cirrhosis, or known biliary disorder
* History of congestive heart failure, or congenital/acquired prolonged QT syndrome/other cardiac diseases predisposing to prolonged QTc
* Hemoglobin \< 8.0 g/dL
* Platelets \< 50,000 cells/mm3
* Confirmed QTcF value \> 450 msec, regardless of sex, at Screening or Day 1
* Current (defined as taking the medication within 14 days of Day 1) or anticipated treatment with medication considered prohibited or restricted as per Appendix II. Certain medication will be carefully evaluated as acceptable, see Appendix II.
* Participation in an experimental drug and/or HIV-1 vaccine trial(s) within the previous 30 days
* Child in governmental care, e.g. child is a ward of the state. Note: This criterion does not apply if the child is officially adopted by a family/guardian.
6 Years
17 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
PHPT Foundation
UNKNOWN
Hospital Universitario 12 de Octubre
OTHER
Cromsource
INDUSTRY
PENTA Foundation
NETWORK
Responsible Party
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Locations
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The George Washington University, Children's National Health System
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Hospital Geral de Nova Iguaçu
Nova Iguaçu, , Brazil
Hospital Federal dos Servidores do Estado
Rio de Janeiro, , Brazil
FAM-CRU
Cape Town, , South Africa
King Edward VIII Hospital
Durban, , South Africa
Rahima Moosa Mother and Child Hospital
Johannesburg, , South Africa
Wits Reproductive Health and HIV Institutel
Johannesburg, , South Africa
Kalafong Hospital
Pretoria, , South Africa
PHRU
Soweto, , South Africa
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHIELD (Penta22)
Identifier Type: -
Identifier Source: org_study_id
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