AIDS clinical research continues

March 9, 2000

Judith Zwolak

Clinical AIDS research will continue at Tulane despite the National Institutes of Health's decision to stop funding a joint Tulane-Louisiana State University program that tests various AIDS treatments on HIV-positive individuals. In a decision last month, the NIH's National Institute of Allergy and Infectious Diseases (NIAID) decided not to renew its $1.5 million annual grant to the Tulane/LSU Adult AIDS Clinical Trials Unit (ACTU).

The government institute cited the ACTU's failure to enroll enough patients, particularly African Americans and women, in its studies as one of the reasons for not renewing the grant. Tulane and LSU are currently appealing the decision and will complete all of the current studies, says Juan Lertora, principal investigator of the center and professor of medicine.

"I want to reassure the patients and the community that we are not shutting down," Lertora says. "All of our patients already in studies will be continued on those studies and receive the appropriate care. Also, the clinical research on HIV and AIDS will continue in parallel with the NIH-sponsored research we have always had and the pharmaceutical-sponsored protocols."

Lertora also stresses that the federal government's decision doesn't affect the funding of the Tulane/LSU Pediatric AIDS Clinical Trials Unit. Besides the adult and pediatric ACTUs, the other NIH-sponsored group at Tulane performing clinical research on HIV and AIDS is the Louisiana Community AIDS Research Program (LaCARP).

One of 15 units of the NIAID's Community Programs for Clinical Research on AIDS, LaCARP is a community-based program that started in 1989. The program conducts studies on the management of AIDS and its complications, with an emphasis on recruitment of a patient population that reflects the diversity of those infected with HIV. It has enrolled 1,000 study participants since its inception.

"The orientation of LaCARP is to provide HIV/AIDS research within primary care settings," says David Mushatt, principal investigator of the program and associate professor of medicine.

Operating at seven sites in New Orleans and Baton Rouge, the program currently enrolls 144 patients in studies that range from finding the best combination of anti-HIV drugs for people recently diagnosed with the virus to studying the long-term effects of drug therapy on HIV-positive individuals. Last month, the NIAID announced that LaCARP will continue to receive federal funding for this year, Mushatt says.

Next year, the program will conduct an external peer review that will determine future funding from the government. "We're quite optimistic that LaCARP will be refunded," Mushatt says. Mushatt says the program has new studies that will explore various aspects of anti-AIDS treatments. One of these studies will evaluate how best to ensure that HIV-infected people abide by their treatment regimens.

"The No. 1 reason for people failing therapy is less-than-optimal adherence to treatment," he says. In the study, some participants are assigned a medication manager who explains the importance of the treatment schedule and keeps in regular contact with his or her participants.

Other participants receive an electronic reminder device that flashes and beeps to signal them to take their medicine. A third group of participants receives help from both the device and the medication manager while a control group has the assistance of neither.

"We want to see if these interventions help," Mushatt says. "It's not just whether they take their pills, but whether they do better over the long term."

A new study starting at LaCARP this month will examine how to best treat individuals who are resistant to various standard anti-HIV medications.

"There are a growing number of people in this category because many HIV patients have been around for a long time and have been on different therapeutic regimens," Mushatt says. "Now, their regimens are beginning to fail and their viral load is going back up."

One of the biggest challenges LaCARP and other AIDS clinical research programs face is enrolling enough patients in their studies, Mushatt says. The wide availability of free anti-AIDS drugs through government programs, Medicaid or private insurance as well as the drugs' improved effectiveness have taken away much of the incentive to participate in research, he says.

"The other thing that we're up against is a persistent skepticism on the part of the minority community about participating in research," he says. "This probably goes back to Tuskegee and other incidents where minorities were abused by the system."

Mushatt says AIDS researchers must do a better job educating the community about the importance of African-American participation in research.

"I think minorities have an inalienable right to part of this research," he says. "They are helping their fellow patients. They're helping people in the future and they're also helping themselves."

Tulane's other AIDS clinical trials with adult participants are those sponsored by pharmaceutical companies such as Merck, Glaxo-Wellcome and Pfizer. The principal investigator of these studies is Newton Hyslop, chief of the infectious diseases section of the Department of Medicine.

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