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NEVADA AIDS AND RESEARCH SOCIETY CLINICAL UPDATE

October 2003

The following is a list of clinical studies for HIV positive patients that are conducted by the Nevada Aids and Research Society (NARES) in conjunction with the UMC Wellness Center.

Tipranavir Expanded Access Program

Tipranavir is the first in a new class of nonpeptidic protease inhibitors (NPPIs) and has been shown to be active in vitro to viral strains resistant to other protease inhibitors (PI’s).

A phase III clinical trial using tipranavir boosted with ritonavir is now available for qualifying patients. The trial is enrolling highly treatment-experienced patients to determine the safety and efficacy of tipranavir/ritonavir containing regimen versus an active control arm for 48-96 weeks.

Minimum requirements for inclusion into the study include:

1. A viral load of >1,000 copies/ml at screening while currently on a PI-containing regimen and < 50 CD4 cells.
   
   
2. Have previously been on at least one antiretroviral from each class, including two protease-inhibitor based regimens for at least three months.
   
3. At least one resistance-conferring PI-mutation documented from a genotype report.

1. HIV vaccine trial in patients that are already infected with HIV and are undergoing treatment with antiretrovirals.
   
   
2. A study looking at the differences between abacavir (Ziagen) plus lamivudine (Epivir) plus efavirenz (Sustiva) versus efavirenz (Sustiva) plus tenofovir (Viread) plus FTC (similar to lamivudine) in antiretroviral naïve patients.