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Trial record 1 of 1 for:    NCT04648280
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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

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ClinicalTrials.gov Identifier: NCT04648280
Recruitment Status : Not yet recruiting
First Posted : December 1, 2020
Last Update Posted : December 1, 2020
ViiV Healthcare
PHPT Foundation
Hospital Universitario 12 de Octubre
Information provided by (Responsible Party):
PENTA Foundation

Brief Summary:
In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance. It will also assess the acceptability and swallowability of formulation among the pediatric population. The dose selection of FTR for children and adolescents ≥20kg utilized a population pharmacokinetic (POP PK) model-based approach to achieve similar adult TMR exposures following FTR 600mg BID administration with combination therapy that was demonstrated to be safe and effective in the FTR Phase 3 BRIGHTE study in HTE patients.

Condition or disease Intervention/treatment Phase
HIV Infections With Multi Drug Resistant Virus Drug: Fostemsavir Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single-arm Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 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 Antiretroviral (ARV) Resistance
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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
Drug: 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

Primary Outcome Measures :
  1. Occurrence of the following events through Week 24 [ Time Frame: 24 weeks ]
  2. AUC(0-tau) [ Time Frame: at week 1, 4, 12, 24, 48 ]
  3. Cmax [ Time Frame: at week 1, 4, 12, 24, 48 ]
  4. Ctau of temsavir across weight bands [ Time Frame: at week 1, 4, 12, 24, 48 ]

Secondary Outcome Measures :
  1. Proportion of patients with HIV-1 RNA <50 copies/mL [ Time Frame: at 24 weeks and 48 weeks ]
    To evaluate the antiviral activity of fostemsavir + OBT

  2. Change in log10 HIV-1 RNA from baseline [ Time Frame: at 24 weeks and 48 weeks ]
  3. Occurrence of: AEs, treatment-related AEs, AEs of Grade 3 or higher, serious AEs, and AEs leading to premature study treatment discontinuation. [ Time Frame: at Week 48 and at the end of Study ]
  4. Occurrence of WHO 3 or 4 defining events, or death [ Time Frame: up to 156 weeks ]
  5. efficacy of fostemsavir plus OBT [ Time Frame: up to 156 weeks ]
    changes from baseline in CD4+ T cell counts and the percentage of CD4 + T-cells

  6. Emergence of genotypic or phenotypic resistance to Temsavir and components of OBT [ Time Frame: up to 156 weeks ]

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female HIV-1 infected paediatric participants from 6 years old and weighing at least 20 kg to less than 18 years of age.
  • 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:

Medical History and Concurrent Diseases:

  • 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.
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Responsible Party: PENTA Foundation
ClinicalTrials.gov Identifier: NCT04648280    
Other Study ID Numbers: SHIELD (Penta22)
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action