RECRUITING

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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Conditions

HIV Infections with Multi Drug Resistant Virus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-06-30
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04648280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * 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).
  4. * Documented resistance to at least one component of the current failing regimen per screening resistance testing.
  5. * 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.
  6. * 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.
  1. * Unable to comply with dosing requirements (to swallow solid pharmaceutical form of the investigational medicinal product)
  2. * Unable to comply with study visits
  3. * Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the participant unable to take oral medication.
  4. * 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
  5. * Pregnancy and breastfeeding
  6. * Chronic untreated Hepatitis B virus (HBV) (however, participants with chronic treated HBV or spontaneously remitted HBV are eligible)
  7. * HIV-2 infection
  8. * Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN and bilirubin ≥1.5xULN (with\>35% direct bilirubin)
  9. * History of unstable liver disease, decompensated cirrhosis, or known biliary disorder
  10. * History of congestive heart failure, or congenital/acquired prolonged QT syndrome/other cardiac diseases predisposing to prolonged QTc
  11. * Hemoglobin \< 8.0 g/dL
  12. * Platelets \< 50,000 cells/mm3
  13. * Confirmed QTcF value \> 450 msec, regardless of sex, at Screening or Day 1
  14. * 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.
  15. * Participation in an experimental drug and/or HIV-1 vaccine trial(s) within the previous 30 days
  16. * 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.

Contacts and Locations

Study Contact

Pablo Rojo
CONTACT
7169822
pablorojoconejo@netscape.net
Alessandra Nardone
CONTACT
7169822
alessandra.nardone@pentafoundation.org

Study Locations (Sites)

The George Washington University, Children's National Health System
Washington, District of Columbia, 20010
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: PENTA Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30
Study Completion Date2028-06

Study Record Updates

Study Start Date2022-06-30
Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

  • HIV Infections with Multi Drug Resistant Virus