(3rd)A5271038 rollover for subjects discontinuing UK-453,061 protocols

• Research type

  Research Study

• Full title

  A phase 2B/3 open-label rollover study for subjects discontinuing from the UK-453,061 protocols for the treatment of HIV-1 infected subjects.

• IRAS ID

  15723

• Sponsor organisation

  Pfizer Inc, 235 East 42nd Street, New York, NY 10017

• Eudract number

  2008/006049−26

• ISRCTN Number

  N/A

• Research summary

  The latest UNAIDS 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 may 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. In early clinical studies it did not appear to have as much of the kinds of side effects that other drugs like it do. So, UK 453,061 may be an important newaddition to the drugs that work against these common kinds of HIV virus.This is a 12 month study to determine the long term safety of subjects who participated in the UK-453,061 protocols and discontinued treatment because their treatment was not working or for other reasons. Antiretroviral medications will be selected by the subject??s study doctor on the basis of laboratory tests, treatment history and safety considerations.UK-453,061 will not be part of the combination of antiretroviral medications.About 200 subjects will be in this study from about 15 countries. The study doctor and a Pfizer doctor will be reviewing the data from the study regularly. Data includes standard of care laboratory tests (HIV-related tests that you??re primaryphysician would routinely take), collection of symptoms, side effects and any medications that are being taking.This study is funded by Pfizer.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0803/38

• Date of REC Opinion

  29 Apr 2009

• REC opinion

  Further Information Favourable Opinion