Boehringer Ingelheim

Boehringer Ingelheim Initiates SPRING Study of Aptivus(R) (tipranavir) in Diverse Group of Highly Treatment-Experienced HIV-Positive Patients

Ingelheim, Germany (ots/PRNewswire) - 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(R) (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. The SPRING (Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low dose ritonavir (500 mg/200 mg) twice daily IN 400 racially and Gender diverse HIV-positive treatment-experienced population) study is a Phase IIIb, open-label, multicenter, multinational trial with a primary endpoint of treatment response at 48 weeks, defined as having an undetectable viral load of less than 50 copies/mL. 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. (i) 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. (ii) "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. About SPRING The SPRING study will enroll 400 patients in 72 sites in the United States, Canada, Mexico, Germany, Italy, Spain, Argentina and Brazil. Patients 18 years and older will have received prior treatment from at least three classes of antiretroviral agents and have documented resistance to at least one protease inhibitor. At screening, patients will have a CD4 cell count of greater than or equal to 50 cells/mm3 and a HIV-1 viral load greater than or equal to 1,000 copies/mL. Fifty percent of patients will receive standard of care (SOC) 500 mg of APTIVUS boosted with 200 mg of ritonavir twice daily in conjunction with an optimized background regimen for 48 weeks. The remaining 200 patients will additionally be included in the randomized pilot evaluation to assess the impact of TDM on the efficacy of APTIVUS. Both the SOC and TDM groups will have an equal number of patients in the race-gender strata. For additional information on inclusion and exclusion criteria and SPRING study sites, visit www.clinicaltrials.gov. About APTIVUS APTIVUS is a new non-peptidic protease inhibitor which works by inhibiting the viral protease, an enzyme needed to complete the HIV replication process. It is approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors. Based on available clinical and in vitro data, APTIVUS is active against most strains of HIV-1 that are resistant to commercially available protease inhibitors. Currently, phase II and III studies in paediatric and other populations are fully enrolled and ongoing. The most commonly reported side effects of at least moderate intensity in patients enrolled in the RESIST studies taking APTIVUS are gastrointestinal, including diarrhoea, nausea, vomiting and abdominal pain. Fever, fatigue, headache, bronchitis, depression and rash also occurred. Gastrointestinal symptom disorders and elevated transaminase, cholesterol and triglycerides were more frequent in the APTIVUS arm than in the comparator-ritonavir group but necessitated discontinuation of treatment in a minority of cases. APTIVUS boosted with low-dose ritonavir has been associated with reports of hepatic adverse events, which have included some fatalities. These have generally occurred in patients with advanced HIV disease taking multiple concomitant medications. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of liver toxicity. The most common moderate to severe laboratory abnormalities were elevated liver enzymes and elevated lipid levels. Most laboratory abnormalities were asymptomatic and most patients were successfully treated without discontinuation. APTIVUS-containing HAART regimens have been associated with reports of both fatal and non-fatal intracranial hemorrhage (ICH) in some highly treatment-experienced patients. Caution should be used when prescribing APTIVUS/r in patients who may be at risk of increased bleeding or who are receiving medications known to increase the risk of bleeding. APTIVUS does not cure HIV infection/AIDS or prevent the transmission of HIV to others. Patients may continue to develop opportunistic infections and other complications associated with HIV disease. Apart from the EU, APTIVUS has received U.S. marketing authorization by the FDA and was launched there in June 2005. Additional marketing authorizations from different countries have been received or are expected. About Boehringer Ingelheim Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Aptivus(R) (tipranavir), Viramune(R) (nevirapine) is a product of original research done at Boehringer Ingelheim. VIRAMUNE was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs on the market. The company is involved in basic research in that area and is committed to improving HIV therapy by providing physicians and patients with innovative antiretroviral treatment options. Boehringer Ingelheim is actively conducting clinical trial programs to further evaluate APTIVUS and VIRAMUNE for the treatment of HIV-1 infection. The APTIVUS clinical trial program is comprised of ongoing and planned studies in more than 1,400 treatment-experienced patients. In addition to the SPRING study for APTIVUS, Boehringer Ingelheim just announced the initiation of the ArTEN trial, which will compare the efficacy and safety of VIRAMUNE dosed once-or twice-daily versus atazanavir boosted with ritonavir in HIV-positive antiretroviral-naive patients. For more information on Boehringer Ingelheim HIV Franchise, please see www.boehringer-ingelheim.com/hiv. Please be advised This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material. References: (i) Lab Tests Online. American Association for Clinical Chemistry. Therapeutic Drug Monitoring. Available at: http://www.labtestsonline. org/understanding/analytes/thdm/glance.html. Accessed on March 27, 2007. (ii) UNAIDS/WHO: 2006 Report on the global AIDS epidemic Web site: http://www.boehringer-ingelheim.com/hiv http://www.clinicaltrials.gov ots Originaltext: Boehringer Ingelheim Im Internet recherchierbar: http://www.presseportal.ch Contact: Judith von Gordon for Boehringer Ingelheim GmbH, +49-61-32-77-3582, or fax, +49-61-32-77-6601

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