A5271037 Extension Study of Lersivirine for the Treatment of HIV

• Research type

  Research Study

• Full title

  A5271037 - Open-Label Extension Study of Lersivirine for the Treatment of HIV-1 Infection

• IRAS ID

  59482

• Contact name

  Anton Pozniak

• Sponsor organisation

  Pfizer Inc

• Eudract number

  2010-020860-39

• ISRCTN Number

  not issued

• Research summary

  According to estimates from the UNAIDS 2009 AIDS Epidemic Update, around 31.3 million adults and 2.1 million children were living with HIV at the end of 2008. 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 is why it is important to keep discovering new combinations of drugs.Lersivirine is an experimental drug in a class of drugs known as Non-Nucleoside Reverse Transcriptase inhibitors (NNRTls). Lersivirine may be able to keep common kinds of HIV virus low and in early studies lersivirine did not appear to have as much of the kinds of side effects that other similar drugs do. So, lersivirine may be an important new addition to the drugs that work against these common kinds of HIV virus. Study A52710137 is a study for patients who have completed 96 weeks of treatment with lersivirine in the parent study(A5271015). The purpose of the study is to follow patients for long-term safety and to ensure they are still benefitting from their treatment. Patients in this study will continue to be treated with the same doses of the study medications taken in the parent study. The patients will continue to be treated until lersivirine becomes available in their country, development of lersivirine is discontinued or until the patient is no longer benefiting from this treatment.About 165 subjects will be in this study from about 19 countries. The study doctor and the Sponsor will be reviewing the data from the study regularly to make sure the treatments are safe and effective. Data includes safety laboratory tests, physical exams, blood pressure, side effects, and other routine HIV related tests.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0707/70

• Date of REC Opinion

  20 Dec 2010

• REC opinion

  Further Information Favourable Opinion