Last updated on July 2019

PH3b DTG Study in HIV-1 Subjects Completing IMPAACT Study P1093

Brief description of study

Dolutegravir (DTG) is a potent inhibitor of the human immunodeficiency virus type 1 (HIV-1) integrase that has been developed for the treatment of HIV. This is a phase 3b (PH3b), non-randomized, open-label, multi-center, treatment rollover study. The primary objective of this pediatric interventional study is to provide continued access to DTG for eligible subjects who successfully completed participation in the international maternal pediatric adolescent acquired immunodeficiency syndrome [AIDS] clinical trials (IMPAACT) P1093 study (parent study) and who cannot locally access DTG in the public sector. The P1093 study was designed to evaluate the pharmacokinetics (PK), safety, tolerability and antiviral activity of DTG in HIV-1 experienced adolescents and children as well as treatment-naive infants and toddlers. Subjects who have tolerated DTG in the parent study without any significant toxicity leading to the permanent discontinuation of this drug and withdrawal from the parent study will be considered for this open-label continued access study. Subjects will be receiving their age/weight appropriate dose of DTG as defined in the parent study. The objective of this study will be supported through evaluation of serious adverse events. The duration of subject accrual into the study will extend until DTG receives local (by country) regulatory approval . Therefore, subjects enrolled into this study will be those who will benefit from treatment and will continue to receive DTG until local (by country) regulatory approval and commercial or other availability occurs from another source (e.g. government programs, aid programs, assistance programs, etc.). Subjects will be enrolled after all screening procedures have been completed. In most cases, the Screening visit will overlap with the subject's penultimate visit on the parent study (at Week 180 of P1093). Subjects who meet all entry criteria may enroll and will be seen in the clinic every 12 weeks for a safety evaluation and to receive DTG. It is estimated that no more than 300 subjects will be enrolled in this study.

Clinical Study Identifier: NCT03016533

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