Phase III Ritonavir-Boosted Elvitegravir Vs. Raltegravir HIV Study

• Research type

  Research Study

• Full title

  A Multicentre, Randomised, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults.

• IRAS ID

  3510

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2007-004225-26

• ISRCTN Number

  n/a

• Research summary

  The Human Immunodeficiency Virus (HIV) attacks the immune system, which protects the body against disease and infection. HIV infection can be spread through the exchange of bodilfluds, such as blood, semen, and vaginafluds.There is no cure, or vaccine, for HIV. Treatment involves using a combination of medicines (antiretroviral drugs) because HIV can quickly adapt and become resistant to one single treatment.While antiretroviral drugs have been largely successful in reducing the severity and likelihood of death associated with HIV, a significant proportion of patients will eventually experience poor tolerability, toxicity, or the development of resistance to their current regimens. Elvitegravir belongs to a new therapeutic class of drug currently being developed. In trials elvitegravir has produced significant beneficial effects in patients with documented drug resistance. Furthermore, elvitegravir has not shown any side effects above those observed in patients receiving standard care.Gilead Sciences Inc., is sponsoring a study to collect information on ritonavir-boosted elvitegravir. Ritonavir boosting is an effective tool used to improve drug levels that may increase efficacy. HIV-1 infected adults who have had previous antiretroviral treatment and documented drug resistance will be randomly assigned to one of two treatment groups given in combination with a background regimen (BR);Treatment Arm 1: Elvitegravir QD raltegravir placebo BID BRTreatment Arm 2: Raltegravir BID elvitegravir placebo QD BRThis is a double-blind study meaning neither the patient nor the study doctor will know which treatment is being given. The study is also placebo-controlled and double-dummy meaning all patients are given both placebo (drug has no medical effect) and active doses of either elvitegravir or raltegravir. This is a multicentre study which will take place across Europe, Australia, and North America. It is anticipated that approximately 700 patients will be recruited worldwide, 20 of those in the UK

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  08/H0405/40

• Date of REC Opinion

  24 Oct 2008

• REC opinion

  Further Information Favourable Opinion