The first patients have been enrolled in a potentially ground-breaking trial in Uganda for a capsule of granules containing four HIV drugs that can be easily administered to young children. Known as the ‘4-in-1,’ this sweet-tasting ‘fixed-dose combination’ could constitute a quantum leap in care for kids living with HIV, replacing a generation of sub-optimal HIV treatments that are difficult to give to children, or no longer recommended by the World Health Organization (WHO).
The phase I/II study, called LOLIPOP, will provide clinical data on the 4-in-1 in infants and young children. The first children were enrolled at the Mbarara Regional Referral Hospital by Epicentre, which conducts field research in support of Doctors Without Borders/Médecins Sans Frontières (MSF). Epicentre Mbarara is one of three study LOLIPOP study sites in Uganda, along with the Joint Clinical Research Centre and the Baylor College of Medicine, both in Kampala.
“Children with HIV have been deeply neglected until recently,” said Dr Juvenal Nkeramahane, the study coordinator at Epicentre and a medical doctor from Mbarara. “We are proud to be part of this study, and more importantly, we are happy that finally people are investing in paediatric HIV.”
The 4-in-1 is being developed by DNDi and the Indian generic company Cipla Ltd with financial support from Unitaid. It contains the WHO-recommended treatments lopinavir, ritonavir, lamivudine, and abacavir in the form of granules in an easy-to-open capsule that can be sprinkled on food, water, or breastmilk.
Epicentre is screening HIV-positive children at Mbarara Regional Referral Hospital to enrol patients in the trial, while nurses and social workers on Dr Juvenal’s team are teaching caregivers how to administer this innovative treatment.
For more information on the 4-in-1 and our paediatric HIV programme, please read our programme update.
Photo credit: Emmanuel Museruka/DNDi