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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Dolutegravir film-coated tablets will be provided as 50 mg tablets.
Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band.
ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC.
ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC.
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Fort Lauderdale, Florida, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Gaborone, Botswana
GSK Investigational Site
Belo Horizonte, Brazil
GSK Investigational Site
Nova Iguaçu, Brazil
GSK Investigational Site
RibeirAo PretoSP, Brazil
GSK Investigational Site
Rio de Janeiro, Brazil
GSK Investigational Site
Cape Town, South Africa
GSK Investigational Site
Johannesburg, South Africa
...and 7 more locations
Number of Participants With Continued Access to Age Appropriate Formulation of Dolutegravir
Time frame: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Number of Participants With Any Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade or relationship to the study interventions.
Time frame: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Number of Participants With SAEs Leading to Discontinuation of Study Treatment
Time frame: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
Number of Participants With Any Clinical or Laboratory Adverse Events (AEs) Leading to Discontinuation of Study Treatment
Time frame: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal
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