A5271015 UK-453,061 vs efavirenz with Tenofovir DF and emtricitabine

• Research type

  Research Study

• Full title

  A Phase 2b Multicenter, Randomized, Double-Blind, Comparative Trial of UK-453,061, in Combination With Tenofovir DF and Emtricitabine Versus Efavirenz in Combination With Tenofovir DF And Emtricitabine For The Treatment of Antiretroviral-Naïve HIV-1 Infected Subjects (Study Number: A5271015)

• IRAS ID

  7541

• Sponsor organisation

  Pfizer Inc

• Eudract number

  2007-004379-20

• ISRCTN Number

  N/A

• Research summary

  The latest UNAIDS (the Joint United Nations Programme on HIV/AIDS) estimate is that there are now more than33 million people who are infected with HIV (Human Immunodeficiency Virus) worldwide (UNAIDS Epidemic Update, 2007). In people who have access to healthcare, the only means of slowing down the disease is to use several drugs together. However, while using several drugs together has helped keep HIV-infected people healthier longer, the drug combinations may have side effects that may keep people from taking as much of the drug as they need to keep the amount of the virus very low. That’s why it is important to keep discovering new combinations of drugs. UK- 453,061 is a drug that may be able to keep common kinds of HIV low and may have a different set of side effects than similar drugs do. So,UK-453,061 may be an important new addition to the drugs that work against these common kinds of HIV. This is a 96 week study to determine if UK-453,061in combination with tenofovir DF and emtricitabine (Truvada) is safe, what types of side effects it has and whether it works as well as efavirenz when it is taken in combination with tenofovir DF and emtricitabine in HIV-1 infected patients who haven’t been treated with antiretroviral drugs before. About 189subjects will be in this study from about 10 countries. The study doctor and a Pfizer doctor will be reviewing the data from the study regularly to make sure the treatments are safe. Data includes safety laboratory tests, physical exams, side effects and other routine HIV-related tests. This study is funded by Pfizer.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  08/H0707/159

• Date of REC Opinion

  28 Nov 2008

• REC opinion

  Further Information Favourable Opinion