Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
Summary
Dolutegravir is a potent integrase strand transfer inhibitor.
Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing
two nucleoside reverse transcriptase inhibitors and dolutegravir. This is a phase 3b,
non-randomized, open-label, multi-center, two treatment rollover study. The primary objective
of this pediatric interventional study is to provide continued access to age appropriate
formulations of investigational product (dolutegravir), either as Tivicay or as part of fixed
dose combination ABC/DTG/3TC, for eligible participants who previously participated in parent
studies P1093 (NCT01302847) or P2019 (NCT03760458) and who cannot locally access age
appropriate formulations of dolutegravir or ABC/DTG/3TC in the public sector. The P1093 study
was designed to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral
activity of dolutegravir in combination with optimized background regimens in human
immunodeficiency virus type 1 (HIV-1) experienced adolescents and children as well as
treatment naïve infants and toddlers. The P2019 study was designed to evaluate PK, safety,
tolerability and antiviral activity of ABC/DTG/3TC dispersible and immediate release tablets
in HIV-1-infected children. Participants who have tolerated investigational product in the
parent studies without any significant toxicity or signs of virologic failure leading to the
permanent discontinuation of investigational product and withdrawal from the parent study
will be considered for this open label continued access study. Participants will receive
their age/weight appropriate dose of investigational product as defined in the parent study.
The duration of participation in the study will extend until age appropriate formulations of
Tivicay or ABC/DTG/3TC receive local (by country) regulatory approval and are available in
those countries from another source (e.g. government programs, aid programs, assistance
programs, etc.) or the participant is no longer deriving benefit from treatment or meets a
protocol defined reason for discontinuation. Participants will be enrolled after all
screening procedures have been completed. In most cases, the Screening visit will overlap
with the participants penultimate visit on the parent study (at Week 180 of P1093, or Week 36
of the P2019 study). Participants who meet all entry criteria may enroll and will be seen in
the clinic every 12 weeks for a safety evaluation and to receive investigational product. It
is estimated that no more than 300 participants will be enrolled in this study. Tivicay is a
registered trademark of ViiV Healthcare.