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The Body Covers: The XIV International AIDS Conference
Maximum Tolerated Effective Dose of Tipranavir

July 9, 2002

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

  • Tipranavir/Ritonavir: Derivation of Doses That Achieve Effective Plasma Concentrations Above the IC50 for Multiple PI-Resistant HIV-1 Viruses (TuPeB4437)
    Authored by S. McCallister, V. Kohlbrenner, D. Mayers
    View the original abstract


Scott McCallister and colleagues from Boehringer-Ingelheim analyzed the results from several trials to establish the maximum tolerated dose of the protease inhibitor tipranavir (TPV) with an acceptable adverse-event profile and effective IC50 concentrations. There is considerable interest in tipranavir due to its different structure and activity in the setting of considerable protease resistance.

Three studies were reviewed by a panel of expert consultants that included doses of tipranavir 500/ritonavir 100 mg BID, tipranavir 500/ritonavir 200 mg BID, and tipranavir 750/ritonavir 200 mg BID. The morning Cmin levels after 21 days of treatment were available, as was the adverse-event profile and degree of virologic suppression. To be considered for further development, a Cmin level of 20µM was established as the minimum target level. Doses of tipranavir above 1,000 mg had an unacceptable adverse-event profile, so doses less than 1,000 mg were recommended.

Review of the data led to a recommendation to not develop the tipranavir 750/ritonavir 200 mg dose any further because the tipranavir 500/ritonavir 200 mg dose had a similar pharmacokinetic profile and less gastrointestinal side effects.

The result of this review supports the use of tipranavir 500/ritonavir 200 or 100 mg BID which are the doses now being evaluated in a phase IIB trial to further identify an optimal dose for phase III trials.


A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

See Also
More on HIV Medications
More Research on Tipranavir (Aptivus)



  
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Please note: Knowledge about HIV changes rapidly. Note the date of this summary's publication, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this summary. For a complete listing of our most recent conference coverage, click here.

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