Community-based physicians will study promising HIV therapies at four new sites joining the community-based clinical trials network supported by the National Institute of Allergy and Infectious Diseases (NIAID).
Awards to the four new sites and 12 incumbent sites, effective Sept. 1, stem from the recompetition of NIAID's Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). The first-year funding for the 16 five-year awards totals $12 million.
These CPCRA awards strengthen our capability and commitment to offer HIV-infected patients clinical trials of HIV therapies in community settings such as private practices and clinics as well as health centers," says Anthony S. Fauci, M.D., director of NIAID. "The CPCRA uses the expertise of primary care physicians and nurses caring for people with HIV disease and involves these health care professionals in clinical research on AIDS."
NIAID started the CPCRA in 1989, adding Terry Beirn's name in 1991 in honor of the late, former manager at the American Foundation for AIDS Research and health policy consultant for Sen. Edward Kennedy. The CPCRA is one of four HIV clinical trials programs supported by NIAID, which is a component of the National Institutes of Health, a U.S. Public Health Service agency.
As a result of the recompetition, the CPCRA will have units in 15 U.S. cities, providing broad geographic diversity, and will be well positioned to continue conducting HIV treatment research and enrolling an ethnically and demographically diverse patient population," says Jack Y. Killen, M.D., director of the NIAID Division of AIDS (DAIDS). "Through this diversity, the CPCRA extends significant opportunities for participation in clinical research to women, minorities and injection drug users."
The four new sites are Cooper Hospital/University Medical Center in Camden, N.J., Philadelphia FIGHT, Pa., University of Maryland at Baltimore and University of New Mexico Medical Center in Albuquerque.
The 12 renewing CPCRA sites are: AIDS Research Consortium of Atlanta, Inc., Ga., Chicago Community Programs for Clinical Research on AIDS, Ill., Columbia University in New York, N.Y., Denver Department of Health and Hospitals, Colo., Henry Ford Hospital in Detroit, Mich., Legacy-Good Samaritan Hospital and Medical Center in Portland, Ore., North Jersey Community Research Initiative in Newark, N.J., Tulane University Medical Center in New Orleans, La., University of California at San Francisco, Virginia Commonwealth University in Richmond, Washington Regional AIDS Program in Washington, D.C. and Wayne State University in Detroit, Mich.
Peer review committees met in March 1994 to assess applications from 37 candidate organizations seeking to become or renew as CPCRA sites. The committee members considered each site's ability to recruit, screen and enroll an adequate number of patients, including women, minorities and injection drug users, availability of primary care medical services and ability to retain and provide long-term followup of patients as well as to collect and report high quality data.
Of the existing 17 CPCRA units, 16 chose to recompete. The four unsuccessful incumbent sites and the site choosing not to recompete will receive phase-out funding for up to three years to ensure that patients currently enrolled in studies will be followed until the studies are completed.
Since 1989, more than 15,000 patients have enrolled in 23 CPCRA trials. Among these participants, 39 percent are African American, 18 percent are Hispanic, 43 percent are white, 20 percent are women and 35 percent describe themselves as injection drug users. CPCRA study findings include: didanosine and zalcitabine are similarly effective and safe for slowing disease progression in HIV-infected people who no longer benefit from zidovudine.
Currently, finding new ways to prevent and treat opportunistic infections (OIs) associated with HIV infection is the CPCRA's highest scientific priority, explains Lawrence R. Deyton, M.S.P.H., M.D., chief of the Community Clinical Research Branch in DAIDS.
Specifically, ongoing trials examine therapeutic strategies to prevent multiple OIs seen in the late stages of HIV infection, Pneumocystis carinii pneumonia, fungal infections common to HIV-infected women and cytomegalovirus infections. Also, the CPCRA is investigating agents to prevent and treat Mycobacterium tuberculosis and Mycobacterium avium intracellulare.
The CPCRA pursues trials to identify the most effective antiretroviral treatments for patients at various stages of HIV infection. In addition, the CPCRA conducts observational studies that collect information on demographics, HIV diagnosis, treatment and laboratory studies of patients followed in a variety of primary care centers.
As part of the CPCRA network, a statistical center manages research design and data analysis, an operations center offers administrative, technical and educational services and a clinical site monitoring group independently reviews the quality and reliability of data collected in the trials. Michael P. Hedderman, R.N., M.P.H., chief of the Operations and Data Management Section in the DAIDS Community Clinical Research Branch, is the CPCRA project officer.
In addition to the CPCRA, NIAID supports the AIDS Clinical Trials Group, which conducts large, multicenter studies at 57 units based at U.S. universities and medical centers, the Division of AIDS Treatment Research Initiative, a small contract-supported program that conducts small trials to rapidly address critical questions about HIV therapies or innovative treatment approaches, and studies by the institute's Division of Intramural Research, which examine therapies against HIV infection and explore reconstitution of HIV-infected patients' damaged immune systems.
NIAID supports investigators and scientific studies at universities, medical schools, hospitals and research institutions in the United States and abroad aimed at preventing, diagnosing and treating such illnesses as AIDS, tuberculosis and asthma as well as allergies.