Principal Investigator - Dr. Shahin Lockman MD, MPH
Primary Objectives: To provide access to age appropriate formulations of dolutegravir (DTG), either as Tivicay or as fixed dose combination (FDC) abacavir/dolutegravir/lamivudine (ABC/DTG/3TC), in an open-label protocol to eligible subjects who have completed the P1093 or IMPAACT 2019 parent studies.
Secondary Objectives: To assess any serious adverse events (SAEs) and any clinical or laboratory adverse events that lead to the discontinuation of lP (Tivicay or ABC/DTG/3TC/FDC).
Study Design: This is a non-randomized, open-label, multi-center treatment rollover study Tivicay in age appropriate formulations will be provided to eligible subjects transitioning from parent study P1093. ABC/DTG/3TC in age appropriate formulations will be provided to eligible subjects transitioning from parent study IMPAACT 201
Study Population and Size: This study will be conducted among H lV-1-infected children less than 12 years of age across all the participating sites. The subjects will be eligible patients rolled over from parent studies which are IMPAACT P1093 and IMPAACT 2019. A maximum of 300 pediatric subjects could enroll in this study globally, with local potential enrolment of 33 locally (18 from IMPAACT Pl093 and 15 from IMPAACT 2019).
Study Duration: 42 months.
Sponsor: ViiV Healthcare UK Limited.