German drugmaker Boehringer Ingelheim says that it has begun enrolling patients in a Phase IIIb study of its anti-HIV drug Aptivus (tipranavir). The firm explained that the trial, which will seek to recruit treatment-experienced patients from a diverse range of ethnic backgrounds, will examine the drug's safety, efficacy and pharmacokinetics.
The SPIRING trial, will provide subjects with Aptivus in combination with low-dose ritonavir in an open-label examination. The primary endpoint is the number of patients achieving a treatment response, defined as an undetectable viral load, after 48 weeks. Assessment will also be conducted using Therapeutic Drug Monitoring criteria, which examines the concentration of a specified drug in the patient;s blood stream.
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