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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

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