Living + Magazine Issue 1 - Positive Living BC
Living + Magazine Issue 1 - Positive Living BC
Living + Magazine Issue 1 - Positive Living BC
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Vaxgen, Inc. A public forum was<br />
held last month to gauge community<br />
response to the potential impacts<br />
of conducting such a trial.<br />
While the exact details of the<br />
trial design for <strong>BC</strong> were not available<br />
at the time this publication<br />
went to the printers, the Vaxgen<br />
website does provide information<br />
about the design of North American<br />
study of AIDSVAX.<br />
This study will be a<br />
randomized, double-blind, placebo-controlled<br />
trial to be conducted<br />
at multiple sites. That<br />
means neither the volunteers nor<br />
the administrators of the study<br />
will know which volunteers will<br />
receive the vaccine and which will<br />
receive a placebo.<br />
The North American trial will<br />
enroll 5,000 male and female volunteers<br />
between the ages of 18<br />
and 60 who do not have HIV-1<br />
infection but are at risk of acquiring<br />
HIV-1 infection by sexual contact.<br />
Injection drug users will not<br />
be enrolled in this North American<br />
trial.<br />
Two participants out of three<br />
will receive investigational vaccine;<br />
the other third will receive<br />
a placebo. Volunteers in the<br />
blinded study will receive a total<br />
of seven vaccinations over the<br />
three-year period. Following the<br />
first vaccination, a subsequent vaccination<br />
will be given 1 month, 6<br />
months, 12 months, 18 months,<br />
24 months and 30 months later.<br />
Follow-up visits to assess the<br />
tolerability to the vaccine<br />
(reactogenicity) will be conducted<br />
two weeks after each vaccination.<br />
Volunteers will use diary<br />
cards to assist them in recording<br />
and recalling symptoms after each<br />
immunization. During every<br />
study visit, participants will be assessed<br />
for possible side effects,<br />
blood will be drawn to study the<br />
immune response to the vaccine,<br />
and some blood and cells will be<br />
stored for future research.<br />
Follow-up will continue for six<br />
months after the last vaccination<br />
is administered. Volunteers will<br />
also be tested for HIV-1 infection<br />
at six-month intervals. Additional<br />
HIV testing is available through<br />
the study centers in the event volunteers<br />
have concerns about potential<br />
exposures. Risk-taking<br />
behavior will be assessed and extensive<br />
counseling on methods<br />
for reducing potential exposures<br />
to HIV will be provided at sixmonth<br />
intervals.<br />
Volunteers who become HIV-1<br />
infected during the study will be<br />
followed more intensively – every<br />
four months for 24 months or<br />
until the study closes, whichever<br />
is longer. They will have measurements<br />
of their HIV viral load and<br />
CD4 counts performed and provided<br />
to them. The infecting virus<br />
will be genotyped and the envelope<br />
region compared to the<br />
vaccine strains.<br />
The use of antiretroviral medications<br />
by participants who become<br />
infected during trial participation<br />
will be permitted. However,<br />
these medications will not be<br />
provided by the study.<br />
More information is available<br />
at: www.cfeweb.hivnet.ubc.ca or<br />
www.vaxgen.com<br />
<strong>BC</strong> Research Centre gets<br />
$1 million to research pot<br />
The Canadian HIV Trial Network<br />
and Community Research Initiative<br />
will get $1 million to research<br />
the medical benefits of pot.<br />
It is expected that there will be<br />
up to 100 people across Canada<br />
participating in this clinical trial.<br />
And the federal department of<br />
health confirmed that they are<br />
also reviewing a business plan to<br />
develop a government-approved<br />
marijuana-growing operation.<br />
The revelations come on the<br />
heels of a recent decision by a<br />
PWA in Ontario to take the federal<br />
government to court for dragging<br />
it’s feet after his request<br />
to receive approval<br />
to smoke medicinal pot<br />
was stalled. Other lower<br />
courts have all dismissed<br />
criminal charges against<br />
people with cancer and<br />
AIDS for possession of<br />
marijuana.<br />
The federal government will<br />
also put out a request for additional<br />
research proposals and provide<br />
$1.5 million in funding for<br />
approved projects.<br />
imagine...<br />
M<br />
the possibilities.<br />
news<br />
reel<br />
NEWS<br />
FROM<br />
HOME<br />
AND<br />
AROUND<br />
THE<br />
WORLD<br />
JULY/AUGUST 1999 • LIVING + 7