Boehringer Ingelheim Expands International Compassionate Use Program for Anti-HIV Drug Tipranavir
"Boehringer Ingelheim recognizes the urgent unmet need for potent drugs that are effective against HIV resistant to currently available protease inhibitors," said Dr. Andreas Barner, Member of the Board of Managing Directors of Boehringer Ingelheim. "We are committed to the rapid development of tipranavir and are pleased to be able to provide patients early access to this important drug."
The Compassionate Use Program is the result of a collaborative effort between Boehringer Ingelheim, the HIV treatment advocacy community and local governments to make tipranavir available to HIV-positive patients in need of drugs potent against resistant virus. Resistance to currently available anti-HIV drugs is an increasingly prevalent concern for HIV-positive patients worldwide.
Tipranavir Compassionate Use Program Overview
The tipranavir Compassionate Use Program is enrolling HIV-1 patients over the age of 18, who are triple-antiretroviral class-experienced with at least two previous PI-based regimens. There are no viral load or CD4+ cell count restrictions for the Compassionate Use Program planned. However, the compassionate use protocol may vary from country to country due to differences in local legal regulations.
All countries participating in the tipranavir Phase III clinical trial program are eligible to take part in the international Compassionate Use Program. Physicians in participating countries who would like to enroll patients in the program should contact their local Boehringer Ingelheim office for more information.
Tipranavir
Tipranavir is a non-peptidic protease inhibitor currently in Phase III of clinical development - the final stage of testing prior to the submission of data to worldwide regulatory authorities for review and consideration for marketing approval. The tipranavir RESIST Phase III clinical trial program is one of the largest study programs ever undertaken for HIV-positive patients previously treated with three classes of antiretrovirals.
Based on available clinical and in vitro data, tipranavir appears to remain active against many strains of HIV-1 that may be resistant to other commercially available protease inhibitors. Ongoing studies are designed to confirm these data.
In studies to date, tipranavir has been well tolerated by most patients. The most commonly reported adverse events across all clinical trials, similar to those seen in other PI-regimen trials, were diarrhea, nausea, fatigue, headache and vomiting.
Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Viramune® (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. Boehringer Ingelheim is committed to the rapid development of the investigational non-peptidic protease inhibitor (NPPI) tipranavir in phase III clinical trials and recently acquired the nucleoside analogue (NRTI) MIV-310 currently in phase II development. The company is involved in basic research and is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.
Related links:
http://www.boehringer-ingelheim.com/hiv
Contact:
Boehringer Ingelheim GmbH
Corporate Division Communications
Judith von Gordon
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 35 82
Fax: +49/6132/77 66 01
E-mail webmaster@ing.boehringer-ingelheim.com
References:
1 Tipranavir Abstracts Presented at 9th European AIDS Conference, October 2003:
Abstract #7.2/3. Long-term 80-week follow-up of highly treatment-experienced (HTE) patients on tipranavir-based antiretroviral therapy (BI 1182.2).
Abstract #7.2/2. Tipranavir/ritonavir (TPV/r) demonstrates potent efficacy in multiple protease inhibitor (PI)-experienced patients at 24 weeks: BI 1182.52.
Boehringer Ingelheim International de compasiune extinde programul pentru utilizare anti-HIV de droguri tipranavir - Boehringer Ingelheim Expands International Compassionate Use Program for Anti-HIV Drug Tipranavir - articole medicale engleza - startsanatate