Drug Utilization Study of Stribild in Adults with HIV

  • Research type

    Research Study

  • Full title

    A Prospective, Observational Drug Utilization Study of Stribild® in Adults with HIV-1 Infection

  • IRAS ID

    157257

  • Contact name

    Anton Pozniak

  • Contact email

    anton.pozniak@chelwest.nhs.uk

  • Sponsor organisation

    Gilead Sciences Inc.

  • Research summary

    The purpose of the study is to investigate the safety and effectiveness of Stribild®, an anti-HIV drug that has recently been approved by medical authorities in Europe.

    HIV is best treated by taking a combination of different types of antiretroviral drugs, so people with HIV have previously had to take several different tablets every day. More recently, single tablet regimens (STRs) have been developed. This means several different drugs are contained within one tablet, so people only have to take one tablet a day to treat their HIV infection. Stribild® is an STR containing four drugs: elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. While a number of studies have found that it is safe and effective in the vast majority of patients, a small minority of patients have developed kidney problems after taking Stribild®. We would therefore like to collect and analyse clinical information relating to the health of patients taking Stribild, in particular their kidney function. This is so we can see if there any common factors in people who do develop kidney problems after taking Stribild®, and what the best way is to manage these problems.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    14/WM/1029

  • Date of REC Opinion

    20 Jun 2014

  • REC opinion

    Favourable Opinion