ATLANTA
—
Some
400
men
in
Atlanta
and
San
Francisco
are
scheduled
to
take
part
in
a
$3.5
million
study
beginning
later
this
year
to
measure
the
safety
of
a
drug
that
might
be
used
to
prevent
HIV
infection
until
an
AIDS
vaccine
is
found.
The
Centers
for
Disease
Control
&
Prevention
is
funding
the
study
of
the
drug
tenofovir
at
the
AIDS
Research
Consortium
of
Atlanta
and
with
researchers
in
San
Francisco
as
an
alternative
to
a
vaccine.
“We
need
to
explore
every
possibility
for
preventing
new
infections,
including
biomedical
solutions,”
said
Dr.
Lynn
Paxton,
CDC
section
chief
for
sexual
transmission
and
intravenous
drug
use
studies.
In
2001,
the
Food
&
Drug
Administration
approved
the
drug,
also
known
as
Viread,
to
fight
HIV.
People
who
are
HIV-positive
can
now
use
Viread
in
combination
with
other
HIV
medications,
but
the
new
CDC
study
would
examine
the
safety
of
Viread
as
a
prevention
pill,
specifically
in
high-risk,
HIV-negative
men
who
have
sex
with
men.
Tenofovir
is
taken
once
a
day,
is
proven
safe
in
people
with
HIV
and
has
garnered
promising
data
in
tests
on
monkeys,
all
factors
in
why
the
CDC
wants
further
research
on
the
drug,
said
Dr.
Melanie
Thompson,
principal
investigator
at
ARCA.
A
small
number
of
monkeys
given
tenofovir
prior
to
SIV
exposure
did
not
contract
SIV,
the
monkey
form
of
HIV,
according
to
Thompson.
A
preventative
measure
like
Viread
would
be
useful
in
combating
HIV
because
an
AIDS
vaccine
isn’t
yet
a
reality,
said
Jim
Rooney,
vice
president
of
clinical
research
at
Gilead,
the
biopharmaceutical
company
that
manufactures
the
drug.
“We
desperately
need
a
vaccine,
but
unfortunately
it
doesn’t
look
like
one
is
going
to
be
available
in
the
near
term,”
Rooney
said.
“It
could
be
an
effective
alternative
strategy
for
preventing
HIV
infection.”
Gilead,
based
in
Foster
City,
Calif.,
donated
the
Viread
needed
for
the
CDC
study,
which
will
measure
the
side
effects
of
the
pill
in
participants
over
a
two-year
period.
Half
of
the
study
participants
will
receive
a
placebo
and
half
will
receive
the
drug.
In
HIV-positive
people
who
take
Viread,
side
effects
include
upset
stomach,
nausea
and
diarrhea,
based
on
past
studies
conducted
by
Gilead,
Rooney
said.
More
serious
hazards
include
kidney
toxicity
and
bone
fractures,
which
result
from
a
loss
of
bone
density,
Rooney
said.
But
participants
in
the
new
study,
which
will
probably
begin
this
summer
in
Atlanta,
would
be
forewarned
of
the
side
effects
and
monitored
for
kidney
and
bone
density
abnormalities,
Thompson
said.
The
study
will
also
provide
information
on
whether
participants
alter
their
sexual
behavior
while
taking
the
drug,
according
to
Paxton.
“If
other
research
finds
that
this
approach
is
effective,
then
data
from
this
study
on
long-term
safety
for
uninfected
men
and
its
impact
on
risk
behavior
will
be
invaluable,”
Paxton
said.
But
researchers
want
to
be
clear
that
the
pill
is
not
a
proven
preventative
measure
against
HIV,
Thompson
said.
“There
are
multiple
risks
associated
with
taking
the
drug
—
not
the
least
of
which
is
that
if
people
think
they
can
use
tenofovir
instead
of
condoms,
they
may
be
at
even
higher
risk
for
HIV
infection,”
Thompson
said.
Researchers
seek
HIV-negative
men
who
have
sex
with
other
men,
ages
18
to
60,
for
the
study,
which
pays
$25
per
visit.
It
is
critical,
Thompson
said,
for
black
and
Latino
men
to
apply.
Free
rapid
HIV
testing
will
be
offered
for
participants
throughout
the
study.
The
CDC
study
in
Atlanta
and
San
Francisco
is
part
of
a
larger
study
of
the
drug,
including
a
$2.1
million
study
by
the
National
Institutes
of
Health
and
a
$6.5
million
study
by
the
Bill
&
Melinda
Gates
Foundation,
according
to
CDC.
The
Gates
Foundation
study
will
use
1,200
women
and
400
heterosexual
men
in
Africa.
The
NIH
trial,
conducted
by
the
University
of
California
in
San
Francisco,
is
testing
900
Cambodian
women.
