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Body Positive's (now the Southwest Center for HIV/AIDS) history of partnership with pharmaceutical companies for clinical trial research has resulted in hundreds of thousands of individuals worldwide taking antiviral drugs that have earned Federal Drug Administration approval. Following is an article from the Arizona Republic which depicts the history of clinical trails the Southwest Center for HIV/AIDS over the years.
Az drug trials site gives hope to HIV patients
The Arizona Republic
Published: 10.08.2007
PHOENIX - It started more than a decade ago when a doctor and an activist set out to answer a question.
What was the best way to ensure metro Phoenix residents infected with HIV got better, quicker access to the top drug therapies?
At the time, pharmaceutical companies were testing promising treatments, but metropolitan Phoenix residents largely were shut out from powerful new drug combinations that could save their lives.
"You can imagine how frustrating it was for people to learn there were treatments out there that they could not access," said Kirk Baxter, founder of the Body Positive center in Phoenix. "People were dying routinely. We figured the only solution for us was to roll up our sleeves and go to work."
Baxter and Dr. Andy Myers decided to mail cold-call letters to pharmaceutical companies looking to test experimental drug therapies.
The message: Body Positive was ready and willing to host clinical drug trials.
In the mid-1990s, pharmaceutical giant Roche Holdings was the first to bite, introducing a test for the nation's first protease inhibitor Saquinivir in Phoenix and other clinical sites nationwide.
"We did a very good job with them," said Myers, Body Positive's medical director of clinical trials. "The HIV clinical research community in our country is not very big, so it doesn't take very long to get a reputation among pharmaceutical companies."
Now Body Positive operates a nationally recognized clinical trial site used by pharmaceutical companies testing AIDS drugs.
The center has conducted more than 100 drug studies in the past decade.
More than two dozen drugs have passed muster with the Food and Drug Administration and made their way to pharmacy shelves.
The powerful drugs have slashed the annual death rate of HIV-positive patients, increased life expectancy and improved quality of life.
Body Positive's drug-testing pipeline now consists of more than a half-dozen drugs with pharmaceutical companies such as Abbott Laboratories, Merck and Hoffman La Roche.
Among the more meaningful trials under way are studies of potential vaccines to ward off the deadly disease that killed an estimated 2.9 million people worldwide in 2006.
Patients who enroll in the trials must sign a consent form. They also must be screened with blood tests and offer a detailed medical history.
Erin Starr, 27, of Phoenix, enrolled in Merck's vaccine trial at Body Positive three years ago. She wanted to help her brother, who is HIV-positive.
After reviewing a thick packet of documents describing potential risks of joining the study, she returned week after week to have her blood drawn and checked.
She expects to visit the center 26 times over five years for blood checks, although her visits are much less frequent now than in the first year.
"When I saw this opportunity to give back to the community, I thought it would be a nice thing to do," Starr said.
More than 11,600 Arizonans have HIV or AIDS, and nearly 70 percent of those who are infected live in Maricopa County, according to the Arizona Department of Health Services.
The number of people living with the disease is growing, in part because of drugs that help people live longer.
Maricopa County health officials often refer HIV patients to Body Positive's clinical trials so they have access to new drug therapies that can attack the disease.
The experimental drugs are especially important to patients whose bodies have grown resistant to existing drugs.
"We have clients that we identify and refer to Body Positive," said Seema Sewell, a Maricopa Health Department program manager overseeing HIV infection control.
"Sometimes that is the only way they can get care," Sewell said.
Body Positive has a $3.5 million annual budget and serves about 1,500 HIV-positive clients each year.
In addition to clinical trials, the center provides behavioral health services, support groups, wellness programs and a vitamin and herb shop.
But the clinical trial program is perhaps the most entrepreneurial element of the organization's mission.
Pharmaceutical companies pay most of the tab for the trials, providing free drugs and paying for blood screens for all enrolled patients.
Abbott said it sought out Body Positive to test its Kaletra drug because of the center's reputation.
"Abbott has a long history working with Body Positive as a Kaletra trial site and with clinical investigator Dr. Myers," said Julie Herlocker, an Abbott spokeswoman.
Even though pharmaceutical companies pay most trial costs, Body Positive still spends about $200,000 each year to support the program.
A major part of those costs are for "expanded access" trials, officials said.
Those tests are for post-trial clients who need drugs that have not yet been approved by the FDA.
And Body Positive increasingly is seeking to help offset the at-times harmful effect of HIV drugs through wellness services.
The federal government slashed about $600,000 in funding for Body Positive's wellness program two years ago.
The nonprofit group depends on community donations to keep the program going.
Baxter, who was diagnosed with HIV in 1990, credits the combination of FDA-approved drugs and wellness programs that include Eastern medicine therapies for saving his life.
He has experienced many ups and downs.
He was so sick in the 1990s that he was known to carry his meds and intravenous fluids with him to meetings.
His most recent scare was a couple of years ago as his body grew resistant to existing HIV meds. Baxter turned to alternative remedies such as acupuncture and a diet rich with vitamins and herbs.
Today, Baxter feels healthy, but he knows he will need powerful drugs and alternative therapies to stay that way.