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

Launched by PENTA FOUNDATION · Nov 23, 2020

Keywords

ClinConnect Summary

The SHIELD study is a clinical trial aimed at evaluating a new treatment for children and adolescents aged 6 to under 18 who are living with HIV and have not responded well to their current medications. This trial will look at the safety of a combination of a new drug called Fostemsavir (FTR) along with other antiretroviral treatments for those who have shown resistance to multiple classes of HIV medications. The researchers want to see how well the treatment works, how safe it is, and whether the participants can easily take the medication.

To be eligible for this study, participants must weigh at least 20 kg (about 44 pounds) and have a confirmed HIV infection. They should have already tried other HIV treatments that haven’t worked, and there needs to be evidence of resistance to at least two different types of HIV medications. Parents and guardians can expect that if their child or adolescent participates, they will need to attend regular visits for check-ups and follow specific treatment guidelines. It's also essential for participants to be able to swallow pills and be in generally good health, as there are some medical conditions that would exclude them from joining the trial. Overall, this study aims to find better treatment options for young people facing challenges with their HIV care.

Gender

ALL

Eligibility criteria

• 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.