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Biotech / Medical : Agouron Pharmaceuticals (AGPH)
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To: Joe E. who wrote (2312)10/14/1997 12:06:00 PM
From: Biomaven   of 6136
 
Joe:

I don't see the press release implying that these were a pre-treated population. On closer reading, I think that this is actually the following trial, not the one I previously posted:

141W94+3TC+AZT
STUDY OF INVESTIGATIONAL THERAPY FOR HIV
141W94 is an experimental second-generation protease inhibitor. It was designed with the goals of improved absorption, fewer drug interactions and slower development of resistance.

STUDY PURPOSES
To compare the safety, tolerability and effectiveness of different amounts (dosing regimens) of 141W94 in combination with 3TC and AZT.
To study how the body processes 141W94.

TREATMENT GROUPS
All participants will receive AZT (300 mg. twice a day) and 3TC (150 mg. twice a day). In addition they will receive one of the following:
Group Dosing Regimen Total Daily Dose of 141W94
1 141W94 900 mg. every 12 hours (twice a day) 1800 mg.
2 141W94 1050 mg. every 12 hours (twice a day) 2100 mg.
3 141W94 1200 mg. every 12 hours (twice a day) 2400 mg.
4 Placebo every 12 hours (twice a day)

Blinded, placebo-controlled study lasts 12 weeks, with a possible 12 week extension.
All study-related medications, lab evaluations and exams are free of charge.
$10 reimbursement per visit.

Eligibility
HIV-positive, CD4+ count at least 150

Viral load at least 10,000 (by PCR)

No prior treatment with 3TC or protease inhibitors

No pancreatitis within the past 3 years

No active or ongoing AIDS defining opportunistic infection or disease
___________

If I'm right, these were treatment-naive or AZT-only patients.

Peter
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