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Biotech / Medical : Agouron Pharmaceuticals (AGPH)
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To: biodoc who wrote (2310)10/14/1997 11:06:00 AM
From: Biomaven   of 6136
 
biodoc:

It wasn't stated in the press release, but I think it was from the following study:

Title:
PROAB3001: A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination with AZT and 3TC versus AZT and 3TC Alone in Patients with HIV Infection

Purpose:
To see if the new protease inhibitor, 141W94, is safe and effective in treating HIV disease when used with AZT and 3TC.

About the study:
All patients will take AZT and 3TC. Patients are assigned by chance to receive 141W94 or placebo. Neither patients nor their doctors will know which they are receiving until the study ends. All medications are pills and taken by mouth twice a day. After week 16, patients who have two consecutive viral loads of more then 5,000 copies will be allowed to switch to quadruple therapy consisting of AZT, 3TC, 141W94, and 1592U89, an experimental reverse transcriptase inhibitor. Patients will be on study medication for 48 weeks.

Required:

CD4 cell (T-cell) range: at least 200

Viral load range: at least 10,000 copies/mL

HIV positive

Not Allowed:

Any past or current AIDS-defining opportunistic infection

Prior use of any protease inhibitors

Use of more than four weeks of any antiretroviral medications
___________

So if this is the correct study, the patients weren't pre-treated but may have been late, as were some of the Viracept population.

Peter
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