se of Fostemsavir in HIV-1 infected children and adolescents with Multi Drug-Resistant virus

Phase 1

• Conditions: HIV-1 infection in children and adolescents with Multi Drug-Resistant virus; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 20.1Level: LLTClassification code 10020447Term: Human immunodeficiency virus type I infection with other conditionsSystem Organ Class: 100000004862

• Registration Number: EUCTR2020-001029-30-ES
• Lead Sponsor: Fondazione Penta ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-11
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Signed Written informed consent
- Ability to obtain an understood and signed written informed consent from parents/caregivers of the participant, and assent from the participant, when applicable.
Target Population:
- Male and female HIV-1 infected pediatric
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 in Section 8.7.1 for effective contraception.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified