Safety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: a phase 1/2 open label, non-randomised, multicentre trial
| Autor: | Samantha Kuryla, Sharon Nachman, Hedy Teppler, Lynette Perdue, Steven A Spector, Carol Worrell, Lisa M. Frenkel, Terence Fenton, Pearl Samson, Steve Douglas, Carrie Fry, MariPat Toye, Brenda Homony, Bobbie Graham, Carmelita Alvero, Andrew Wiznia, Rohan Hazra, Scott Watson, Anthony Rodgers, Nan Zheng, Edward P. Acosta, Renee Browning, Nancy B. Tustin |
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| Rok vydání: | 2018 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Adolescent Anti-HIV Agents Epidemiology Immunology Administration Oral Integrase inhibitor HIV Infections Article 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Raltegravir Potassium Virology Internal medicine Humans Medicine HIV Integrase Inhibitors 030212 general & internal medicine Child Adverse effect Botswana business.industry Infant Raltegravir 030112 virology Rash CD4 Lymphocyte Count Clinical trial Regimen Treatment Outcome Infectious Diseases Tolerability Child Preschool HIV-1 Female Americas medicine.symptom business Follow-Up Studies medicine.drug |
| Zdroj: | The Lancet HIV. 5:e715-e722 |
| ISSN: | 2352-3018 |
| DOI: | 10.1016/s2352-3018(18)30257-1 |
| Popis: | BACKGROUND: Raltegravir is an integrase inhibitor approved for use in adults and children with HIV-1 infection, but there are no data on the long-term use of this medication in children. We aimed to assess the long-term safety, tolerability, pharmacokinetics, and efficacy of multiple raltegravir formulations in children aged 4 weeks to 18 years with HIV-1 infection. METHODS: In this phase 1/2 open-label multicentre trial (IMPAACT P1066), done in 43 IMPAACT network sites in the USA, South Africa, Brazil, Botswana, and Argentina, eligible participants were children aged 4 weeks to 18 years with HIV-1 infection who had previously received antiretroviral therapy (ART), had HIV-1 RNA higher than 1000 copies per mL, and no exposure to integrase inhibitors. Participants were separated into five age groups and enrolled in six cohorts. Three formulations of open-label raltegravir—adult tablets, chewable tablets, and granules for oral suspension—were added to individualised optimised background therapy, according to the age and weight of participants. The primary outcome at 48 weeks has been previously reported. In the 240-week follow-up, outcomes of interest included graded clinical and laboratory safety of raltegravir formulations during the study and virological efficacy (with virological success defined as HIV-1 RNA reduction of >1 log(10) from baseline or HIV-1 RNA |
| Databáze: | OpenAIRE |
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