Antiretroviral (ARV) therapy against HIV has greatly decreased the AIDS mortality rate which in turn has led to HIV being considered as a chronic disease for adults and children, requiring life-long therapy. Despite the availability of different classes of ARV agents providing a variety of treatment options, treatment failure continues to occur because of ARV drug resistance, drug-associated toxicity and tolerability problems, and poor adherence. New therapies should aim to be convenient and have favourable tolerability and safety profiles to provide alternative treatment options in children and adolescents. In particular, there is a need for new therapies for multi-drug resistant (MDR) paediatric patients, who by definition have failed multiple ARV classes/regimens, have very few remaining therapeutic options, and are often on ARV combinations that are highly individualised and may lack efficacy, safety and tolerability profiles of agents traditionally used in earlier lines of therapy.
What is SHIELD?
Fostemsavir in HIV-1 infected children and adolescents with Multi Drug-Resistant virus
SHIELD trial is setup to evaluate the safety and antiviral activity of fostemsavir when used in combination with optimized background therapy in children and adolescents living with HIV who are failing their current combination antiretroviral therapy and have dual- or triple-class ARV resistance.
SHIELD is a multicentre, open-label, single-arm trial with sites in Spain, South Africa, Italy, Mexico, and the USA.
Penta is the sponsor of the SHIELD trial.
Why is SHIELD needed?
HIV treatment failure may result in the virus developing resistance to one or more antiretroviral agents. Furthermore, resistance mutations to one antiretroviral drug often leads to resistance to multiple drugs in the same class, significantly limiting future therapeutic options. Regimens offered after failing first- and second-line treatment options are often prone to adverse effects which in turn increase non-adherence. Thus, there is an ongoing need for new classes of antiretroviral drugs capable of providing potent, durable antiviral activity against current antiretroviral-resistant viruses. If not prevented, HIV drug resistance can jeopardize the efficacy of antiretroviral drugs, resulting in increased numbers of HIV infections and HIV-associated morbidity and mortality.
What is SHIELD’s goal?
SHIELD will evaluate the safety of 24 weeks of treatment with fostemsavir + optimized background therapy in children and adolescents aged between 6 and 18 who weigh at least 20kg. SHIELD will also evaluate the steady-state pharmacokinetics (which is when the amount of the drug in the blood has built up to a level that is therapeutically effective) of temsavir, the active part of fostemsavir, in children and adolescents living with HIV.
SHIELD is funded by ViiV Healthcare and is sponsored by Penta Foundation.