A5271022 UK-453,061 v's etravirine with combination therapy in HIV

• Research type

  Research Study

• Full title

  A PHASE 2B MULTICENTER, RANDOMIZED, COMPARATIVE TRIAL OF UK-453,061 VERSUS ETRAVIRINE IN COMBINATION WITH DARUNAVIR/RITONAVIR AND A NUCLEOTIDE/NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED HIV-1 INFECTED SUBJECTS WITH EVIDENCE OF NNRTI RESISTANT HIV-1

• IRAS ID

  11493

• Sponsor organisation

  Pfizer Inc

• Eudract number

  2007-004392-19

• ISRCTN Number

  N/A

• Research summary

  The latest UN AIDS estimate is that there are now more than 33 million people who are infected with HIV 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 have side effects that may keep people from taking as much of the drug as they need to keep the amount of the HIV 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 the common kinds of HIV virus low and may work against some but not all viruses that have not responded enough to earlier drugs. In early clinical studies it did not appear to have as much of the kinds of side effects that other similar drugs do. So, UK 453,061 may be an important new addition to the drugs that work against these common kinds of HIV virus. UK-453,061 is part of a class of drugs known as Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs). This is a 96 week study to determine if UK-453,061 in combination with Darunavir/Ritonavir plus a NRTI (Nucleoside Reverse Transcriptase Inhibitor) prescribed for you by your physician is safe, has fewer side effects and works as well as Etravirine when it is taken in combination with Darunavir/Ritonavir plus an optimized NRTI (Nucleoside Reverse Transcriptase Inhibitor) prescribed for you by your physician in HIV-1 infected patients who have been treated with antiretroviral drugs before. Etravirine is another drug in the NNRTI class of drugs.About 189 subjects 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 and effective. There will also be an independent panel of experts who review the data from the study on a regular basis to ensure safety as well. Data includes safety laboratory tests, physical exams, blood pressure, 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

  09/H0803/12

• Date of REC Opinion

  25 Mar 2009

• REC opinion

  Further Information Favourable Opinion