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Shionogi
& GlaxoSmithKline ITG 20001 (S-1360): Antiviral
therapy
A
study to compare different doses of an integrase inhibitor
versus placebo for its anti-HIV effectiveness, tolerability
and safety.
Background
& Objective
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Many
people who are HIV+ and taking medications have strains
of HIV that are resistant to most or all known antiretrovirals.
All of the current anti-HIV drugs inhibit the activity
of two of the HIV enzymes. Integrase inhibitors block
the activity of a different HIV enzyme called integrase,
which helps infected cells produce even more infectious
virus. A completely different class of drugs, such as
integrase inhibitors, could vastly increase the anti-HIV
arsenal and prove especially helpful to those who do
not respond to currently-available classes of medications.
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This
is a new phase II trial to compare antiviral effect,
safety, tolerability and pharmacokintetics (amount of
drug in your blood) of four oral doses of S-1360 versus
placebo. This 10-day study is
for HIV infected volunteers
who have never taken anti-HIV
medications. It will involve two overnight stays
at a local hotel (to be announced later), followed by
a full day of timed blood specimen collections at our
West Hollywood clinic. Volunteers will
be compensated up to $875
for their inconvenience.
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Inclusion
Criteria
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This
study is open to HIV+ adult men and women with no previous
use of anti-HIV medications. Participants must
have no current opportunistic infections. Viral loads
must be between 400 to 50,000 copies/per mL, and T-cell
counts must be 50 or above. Call the clinic (number
below) for questions on specific inclusion criteria.
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Enrolling
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Volunteers
will be compensated up to $875 for their inconvenience.
For
more information about participating in this study
in the Los Angeles area, please call 310/358.2429
or e-mail Corie Castro at ccastro@aidsresearch.org
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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 in September, 2002.
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