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Zerit™
(Stavudine, D4T) Extended Release
For
HIV+ patients who have never taken HIV medications before
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This
study compares the new, investigational, "once a day"
form of d4T (Stavudine) to the "twice a day" (extended
release) form. |
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Objective
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To
look at the antiviral, immunological, safety and toxicity
of the extended release form of d4T. |
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A
Phase II, 48 week study. In addition to d4T, volunteers
will also be on Sustiva and 3TC, a protease inhibitor
sparing regimen (protease inhibitors are not used in this
study). All study drugs are FDA approved for HIV infection—only
the new form of d4T is being tested. This study also includes
2 additional, optional blood tests for which volunteers
will receive $75 per test. |
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Inclusion
Criteria
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a)
Have never used antiretrovirals (for more than 7 days
total)
b) HIV+ man or woman, at least 18 years old
c) Viral load greater than or equal to 5,000 copies
d) T-cell count greater than or equal to 100
e) No active opportunistic infections
f) Women who are not pregnant and willing to use contraceptives
for the duration of the study |
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Status
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Enrollment complete; study ongoing
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We
encourage participation by women and people of color.
This
ad was reviewed and approved by the AIDS Research
Alliance Institutional Review Board on August 15,
2000.
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