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  1. Jan 18, 2022 · Abstract. P1093 is a multicenter, open-label, phase I/II study of pharmacokinetics, safety, and tolerability of dolutegravir plus an optimized background regimen in pediatric participants aged 4 weeks to <18 years with HIV-1.

  2. Abstract. P1093 is a multicenter, open-label, phase I/II study of pharmacokinetics, safety, and tolerability of dolutegravir plus an optimized background regimen in pediatric participants aged 4 weeks to <18 years with HIV-1. Most participants were highly treatment experienced.

  3. We aimed to select dosing for a dispersible tablet formulation of dolutegravir that achieved pharmacokinetic exposures similar to those in adults, and was safe and well tolerated in young children.

  4. Jan 18, 2022 · INTRODUCTION. Adolescents and children with HIV-1 face multiple barriers to antiretroviral therapy (ART) adherence, including logistical challenges related to drug access and age-related factors, as well as issues with formulations, dosing frequency, pill or volume burden, toxicity, side effects, and others ( 1, – 3 ).

  5. Summary. Background Safe and potent antiretroviral medications in child-friendly formulations are needed to treat young children living with HIV-1. We aimed to select dosing for a dispersible tablet formulation of dolutegravir that achieved pharmacokinetic exposures similar to those in adults, and was safe and well tolerated in young children.

  6. Nov 1, 2015 · Vavro C, Ruel T, Wiznia A, Montañez N, Nangle K, Horton J, Buchanan AM, Stewart EL, Palumbo P. Antimicrob Agents Chemother, 66(1):e0164521, 25 Oct 2021 Cited by: 8 articles | PMID: 34694878 | PMCID: PMC8765298. Free to read & use

  7. Nov 10, 2021 · Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Dolutegravir Dispersible Tablets in Infants and Children with HIV-1: Results of the IMPAACT P1093 Study, a Phase I/II Open-Label Trial by Theodore Dumont Ruel, Edward P. Acosta, Jessica P. Liu, Kathryn P. Gray, Kathleen George, Nicole Montañez, Stephanie Popson, Ann M. Buchanan, Ma...