- The Washington Times - Thursday, December 4, 2003

Attracting volunteers with HIV to participate in clinical trials for AIDS treatments has become increasingly difficult, researchers say.

While the chance to try a new AIDS drug was once enough to ensure strong enrollment in such trials, people infected with HIV today are less likely to see the virus that causes AIDS as a killer.

Also, many are doing well on expensive therapies paid for by private insurers or state-run AIDS assistance programs.

“For sure, enrollment is more difficult,” Stephen Karpiak, associate director of research at the nonprofit AIDS Community Research Initiative of America, told Poz, a magazine geared toward people with HIV.

In a telephone interview, Mr. Karpiak said he agrees with an estimate by Dr. Ronald Mitsuyasu, director of the Center for Clinical AIDS Research and Education at the University of California at Los Angeles, that enrollment in HIV drug trials nationwide may be down by as much as 60 percent.

“That’s not an exaggeration,” Mr. Karpiak said.

A nurse with the Boston-based Community Research Initiative of New England agreed in a telephone interview. “It’s definitely true that fewer women and people of color are signing up for clinical trials,” said the nurse, who asked not to be identified.

The news about declining participation in drug trials comes as world leaders stated Monday — World AIDS Day — that the war on AIDS is being lost.

More than 42 million people worldwide are estimated to be living with HIV/AIDS. Of those, about 70 percent live in Sub-Saharan Africa, while 17 percent live in Asia.

“We need to redouble our efforts. This war has more casualties than any other war, as we are losing 3 million people every year,” U.S. Health and Human Services Secretary Tommy G. Thompson said in Zambia, a nation especially hard-hit by HIV/AIDS.

The United Nations is working on a $5.5 billion emergency strategy to supply HIV treatments to 3 million people in developing countries by the end of 2005.

The Centers for Disease Control and Prevention reported recently that the number of HIV infections is soaring among homosexual and bisexual men in the United States.

The results of the CDC study, which used data from 29 states, showed that blacks continue to be the hardest-hit population in terms of HIV, accounting for 55 percent of new cases. There was a 26 percent rise in new HIV diagnoses among Hispanic men and an 8 percent increase among non-Hispanic white men.

Dr. Rob Janssen, head of the CDC’s AIDS division, said in an interview that most of the surge among racial and ethnic HIV cases involved homosexual or bisexual men. Two-thirds of Hispanic HIV patients in the CDC analysis were homosexual.

Women represented nearly 30 percent of new HIV cases between 1999 and 2002, according to CDC data. Women account for the majority of HIV infections acquired through heterosexual contact. Seventy percent of newly infected women contracted the virus through sex with men.

Dr. Calvin Cohen, research director of CRI-New England, said that “women, people of color, and injection-drug users have always been the most reluctant” to join clinical trials for AIDS treatments.

In some cases, an unwillingness to join trials results from suspicions about the trials themselves.

Among the problems encountered are concerns about the safety and effectiveness of the drug, the hassle of making frequent visits to clinics for testing, the large amount of paperwork, and the uncertainty about whether a trial subject will be given the new drug or a placebo.

“There’s less passion for initiating [HIV] therapy studies. People have lost the passion they once had because they recognize current treatments have improved,” Dr. Cohen said.

Still, Dr. Cohen said, “Treatment isn’t perfect. Drugs have long-term toxicity, so people are reluctant to stay on them. … We think we can do better.”

This article was based in part on wire service reports.


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