THE TULANE-LSU AIDS CLINICAL TRIALS UNITS

The Tulane Infectious Diseases Section, working in conjunction with the Tulane Departments of Pharmacology and of Pediatrics, and with the Louisiana State University Medical Center at New Orleans, is a key component in the administration of a unique state resource: the Tulane-LSU Adult and Pediatrics AIDS Clinical Trials Units.

The Adult ACTU is one of only 30 such clinical research centers in a nationwide network called the Adult AIDS Clinical Trials Group (A-ACTG). The Pediatric unit is one of 21 such units nation-wide in the Pediatric AIDS Clinical Trials Group (P-ACTG). Each adult and pediatric unit operates under a cooperative agreement with the Division of AIDS in the National Institute of Allergy and Infectious Diseases.

The mission of each individual AIDS Clinical Trials Unit (ACTU) is to provide an efficient system for determining through clinical research the efficacy and toxicity of therapeutic interventions against Human Immunodeficiency Virus (HIV) infection and its complicating opportunistic infections and malignancies. The mission is accomplished through the recruitment and retention of patients in clinical studies supervised by the ACTGs, by the submission of research and clinical data to the ACTGs, through scholarly communication with researchers in the ACTG, and by the initiation of unique clinical research in the ACTGs.

The researchers of the ACTGs advance new agents from preclinical studies to final FDA approval and make every effort to transfer innovative therapies from the laboratory to the realm of routine patient care. The ACTG structures ensure that the clinical research on treatment efficacy addresses questions of the highest scientific urgency. Its clinical and basic scientific investigators participate in the work of national committees and other study groups organized by the ACTGs. Local units are also expected to undertake pilot studies and interact with pharmaceutical manufacturers in advancing new treatments to larger clinical trials.

The Adult ACTU is a multidisciplinary program, which promotes joint research involving other programs in the departments of microbiology/immunology, medicine, neurology, pathology, pediatrics, pharmacology, psychiatry, and other medical sciences located within Tulane and LSU Medical Centers in New Orleans.

The Adult ACTU consists of a consortium of clinicians, study nurses, clinical laboratory scientists and research laboratory scientists, supported by technical and administrative personnel, who collectively perform the multitude of tasks necessary to study patient volunteers.

From 1987 to 1996 the Tulane-LSU Adult ACTU was under the direction of its founder and first Principal Investigator, Newton E. Hyslop, Jr., M.D., who is Chief of Infectious Diseases at Tulane and Professor of Medicine. Dr. Hyslop now serves as Co-Principal Investigator of the ACTU for Tulane and Director of its Pharmaceutical Studies Division.

Since January 1996 the Tulane-LSU ACTU has been directed by Juan J.L Lertora, MD, Ph.D., Professor of Medicine and Pharmacology, and Chief of the Tulane Clinical Pharmacology Section.

Rebecca A. Clark, M.D., Ph.D., who is Associate Professor of Medicine in the Infectious Diseases Section at Louisiana State University School of Medicine, and Director of its HIV Program, serves as the ACTU Co-Principal Investigator for LSU.

Several other Tulane Infectious Diseases Section faculty members have key roles in this program. Setlur R. S. Rangan, Sc.D., Director of the Retrovirology Laboratory, is the ACTU Virologist. Mark Beilke, M.D., Associate Professor of Medicine and Co-Director of the Retrovirology Laboratory, is an HTLV I/II Specialist and Clinical Virologist for the ACTU. David Mushatt, M.D, Associate Professor of Medicine and Principal Investigator of the Louisiana Community AIDS Research Program, is also an ACTU Infectious Diseases Specialist, as is Susan L.F. McLellan, M.D., Assistant Professor of Medicine.

The two divisions of the Adult ACTU together employ nearly 30 individuals. The clinical research program supports five research nurses and six physicians who carry the major responsibility of evaluating and following research patients.

Study volunteers receive free medications and are not charged clinic fees for study-related visits. Most volunteers are inhabitants of Louisiana, which ranks 13th nationwide in cases of AIDS. New Orleans and Baton Rouge are among the top 12 metropolitan areas in the nation in cases of AIDS per 100,000 population.

The range of protocols is shown by divisions into primary infection (HIV infection), opportunistic infections and malignancies. Also included are protocols of the NIH-supported Mycoses Study Group (MSG), which are also administered by the Tulane Infectious Diseases Section.

Founded as one of the original 19 AIDS Treatment Evaluation Units after a national competition in 1986, this clinical research program has enrolled over 1000 men, women and children into AIDS clinical trials since its funding in January 1987.

The ACTU has established a reputation for excellence in clinical research that has been recognized through (1) its productivity, (2) the inclusion of its program leaders in the national planning efforts, (3) the award of competitive supplements to the main grant (which permitted establishment of a Pediatrics subunit in 1990 and an Adolescent subunit in 1991), (5) by the separate funding in 1991 of the Pediatric program as part of the newly created national Pediatric AIDS Clinical Trial Group, (6) by successful refunding of both the Adult and Pediatric programs and (7) by the interest of pharmaceutical companies in placing important national clinical trials with this program.

The strength of these clinical research programs was also essential to the initial award by the NIH to Tulane, LSU and Charity Hospital to construct the General Clinical Research Center at Charity Hospital. This facility, which opened in January of 1991 and has been refunded in subsequent grant renewal cycles, not only has been the major site for adult and pediatric HIV/AIDS-related clinical trials but has also produced a significant volume of important clinical research on diseases unrelated to HIV infections.