Ritonavir-boosted Elvitegravir in HIV-1 adolescents, GS-US-183-0152

• Research type

  Research Study

• Full title

  A Phase 1B Study of the Safety and Pharmacokinetics of Ritonavir-Boosted Elvitegravir (GS-9137/r) Plus a Background Regimen (BR) in HIV-1 Infected, Antiretroviral Treatment-Experienced Adolescents

• IRAS ID

  8092

• Contact name

  Gareth Tudor-Williams

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2008-003917-29

• ISRCTN Number

  n/a

• Research summary

  Adolescent subjects with long standing HIV infection are in particular need of new classes of drugs that are active against HIV resistant to existing classes of antiretroviral agents. The study drug belongs to a new therapeutic class and has demonstrated activity against drug resistant HIV in laboratory studies. In clinical studies the study drug has produced significant declines in HIV-1 RNA in treatment experienced adults with documented drug resistance. Data in children and adolescents are lacking. The current study is multicentre study in a number of sites in the UK, the US and Canada and is sponsored by a US based pharmaceutical company. This study consists of an open-label 10 day pharmacokinetic evaluation phase in HIV infected adolescents, followed by an optional open-label treatment phase, where all patients will receive the study drug. Pharmacokinetics looks at how well the body absorbs, distributes, metabolizes (breaks down or processes the drug) and eliminates drugs. Subjects recruited in this study will be HIV-1 infected adolescents who are antiretroviral treatment-experienced. The primary objective of this study is to look at the pharmacokinetics and confirm the dose of the study drug. The secondary objective of this study is to see if the study drug is safe and well tolerated in HIV-1 infected adolescents.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  08/H0714/93

• Date of REC Opinion

  10 Nov 2008

• REC opinion

  Favourable Opinion