Boehringer Ingelheim initiates SPRING study of Aptivus® (tipranavir) in diverse group of highly treatment-experienced HIV-positive patients
Boehringer Ingelheim GmbH announced today that it has begun to enroll patients in the SPRING study. The SPRING study will be one of the largest racially and gender diverse international studies of highly treatment-experienced HIV-1 infected patients. The trial will examine the safety, efficacy and pharmacokinetics of Aptivus® (tipranavir) in a racially diverse group of 200 female and 200 male treatment-experienced patients across eight countries in three continents. SPRING is also the largest randomized controlled trial to use Therapeutic Drug Monitoring (TDM) in a study of highly treatment-experienced HIV patients.
“Clinical trials have shown that the efficacy of antiretroviral treatments may vary across races and genders. The 48-week data from the RESIST studies have already demonstrated the efficacy of Aptivus in treatment-experienced patients, and SPRING is designed to further examine its utility in diverse patients within this population" said SPRING investigator Sharon Walmsley, M.D., professor of medicine, University of Toronto, senior scientist, Toronto Hospital Research Institute, and director, Clinical Research, Immunodeficiency Clinic, Toronto Hospital.
. Patients will also be included in a randomized evaluation to assess the impact of TDM on the efficacy and safety of Aptivus boosted with ritonavir. TDM is the measurement of specific drug levels in a patient’s blood at certain intervals of time that is used to tailor medication dosages to fit the specific needs of the individual patient.1
Worldwide, there are more HIV-positive women than ever before, with nearly 18 million now living with the disease. Women of African and Latin American decent are disproportionately affected and account for a large number of infections in developed countries, including those in Europe.2
“Boehringer Ingelheim is committed to studying the benefits of Aptivus in different treatment-experienced patient populations and hopes that SPRING will play a critical role in advancing knowledge about HIV care,” said Dr. Andreas Barner, Vice-Chairman, Board of Managing Directors and Head of Corporate Board Division Pharma Research, Development and Medicine, Boehringer Ingelheim.
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