NIAID Renews Funding for the Adult AIDS Clinical Trials Group

The National Institute of Allergy and Infectious Diseases (NIAID) has renewed funding for the Adult AIDS Clinical Trials Group (AACTG), the largest clinical trials network in the world. Under the new award, the AACTG will receive $80 million in the first year of a five-year grant. The funding enables the network to continue conducting studies of antiviral interventions, methods to reconstitute the immune system damaged by HIV, and the treatment and prevention of opportunistic diseases and other HIV-related complications.

"Since the beginning of the AIDS epidemic, the AACTG has made enormous contributions in helping people with HIV live dramatically longer and healthier lives," says NIAID Director Anthony S. Fauci, M.D. "AACTG studies have been and will continue to be an invaluable source of scientific data, significantly advancing our ability to treat HIV."

The AACTG consists of a Coordinating and Operations Center, Statistical and Data Analysis Center and 32 AIDS Clinical Trials Units across the country, including new sites in Texas, Tennessee, Pennsylvania, Rhode Island and New York. Chair Robert T. Schooley, M.D., and Vice Chair Constance A. Benson, M.D., of the University of Colorado Health Sciences Center in Denver, will continue to provide the group's executive leadership. Victor DeGruttola, Sc.D., of the Harvard School of Public Health in Boston, will continue to direct the Statistical and Data Analysis Center.

"With a very strong group of internationally recognized and dedicated HIV researchers, the AACTG has remained on the cutting edge of HIV therapeutics and responded rapidly to new scientific opportunities," says Dr. Schooley. Acknowledging the AACTG's effectiveness in turning laboratory discoveries into new intervention strategies at the bedside, peer reviewers rated the network as "outstanding." From its start in 1987, the AACTG has played a pivotal role in defining the standard of care for adults infected with HIV. AACTG trials have evolved from early studies with single-drug regimens to the current drug "cocktails" that make up highly active antiretroviral therapy, or HAART. Other recent AACTG studies have

shown how new combinations of drug regimens can help people who have responded poorly to or exhausted other approaches;

proven the value of HIV-1 RNA levels in the blood as markers of how far the disease has progressed and how beneficial treatments have been;

identified the significance of antiretroviral drug resistance and the reservoirs where HIV remains impervious to treatment;

contributed to the understanding of how HIV destroys immune function and how the immune system can be restored following HAART;

identified regimens for treating and preventing opportunistic infections; and

improved access to clinical trials for women and underrepresented populations within the network's academic and community-based clinical trials units.

Among the future priorities for the AACTG are defining the most effective antiretroviral treatment strategies at each stage of HIV infection, developing new ways to prevent or treat opportunistic infections, and focusing on the growing problem of hepatitis C co-infection with HIV disease. Researchers also will study the interaction between various anti-HIV drugs and seek to lessen metabolic abnormalities and other side effects associated with HAART.

Developing strategies to eliminate reservoirs where HIV lingers within the body will be another important focus. Network clinicians will explore new approaches to augment the immune system in the presence of HIV and will examine promising leads into restoring immune function. The long-term effects of anti-HIV therapeutics will be further scrutinized as the AACTG seeks to improve patients' abilities to tolerate these therapies.

Press release, fact sheets and other NIAID materials are available on the NIAID web site at www.niaid.nih.gov. Background

The AACTG is an outgrowth of NIAID's first major program to evaluate potential treatments for people with AIDS, which began in the summer of 1986. In 1996, the original AIDS Clinical Trials Group branched into two separate programs, the Adult AIDS Clinical Trials Group and the Pediatric AIDS Clinical Trials Group (PACTG). Since 1986, more than 50,000 volunteers have enrolled in AACTG studies, and almost 18,000 children and pregnant women have participated in PACTG studies.

NIAID supports a broad program in HIV therapeutic research. This ranges from basic laboratory science to bench-to-bedside studies, which test new approaches in small numbers of people, to larger clinical trials that recruit patients throughout the country to evaluate the best new ways to treat and manage HIV disease. In addition to the AACTG and the PACTG, other NIAID-sponsored therapeutic research programs include the Acute Infection and Early Disease Research Program, the Terry Beirn Community Program for Clinical Research on AIDS, and the Integrated Preclinical/Clinical Therapeutics Research Program.

AACTG Adult Clinical Trials Units and Principal Investigators

Alabama University of Alabama at Birmingham - Michael S. Saag, M.D.

California Stanford University - Thomas C. Merigan, Jr., M.D. University of California Los Angeles - Ronald T. Mitsuyasu, M.D. University of California San Diego - Diane Havlir, M.D. University of California San Francisco - Mark Jacobson, M.D. University of Southern California Medical Center - John M. Leedom, M.D.

Colorado University of Colorado Health Sciences Center - Robert T. Schooley, M.D.

Florida University of Miami School of Medicine - Margaret A. Fischl, M.D.

Hawaii University of Hawaii - Cecila M. Shikuma, M.D.

Illinois Northwestern University - Robert L. Murphy, M.D.

Indiana Indiana University - Joseph L. Wheat, M.D.

Maryland Johns Hopkins University School of Medicine - John G. Bartlett, M.D.

Massachussetts Harvard Medical School - Martin S. Hirsch, M.D.

Minnesota University of Minnesota Medical School - Henry H. Balfour, Jr., M.D.

Missouri Washington University - William G. Powderly, M.D.

New York Beth Israel Medical Center - Donna Mildvan, M.D. Columbia University - Scott M. Hammer, M.D. New York University Medical Center - Fred T. Valentine, M.D. University of Rochester Medical Center - Richard C. Reichman, M.D.

North Carolina Duke University - John A. Bartlett, M.D. University of North Carolina at Chapel Hill - Charles M. van der Horst, M.D.

Ohio Case Western Reserve University - Michael M. Lederman, M.D. Ohio State University Medical Center - Robert J. Fass, M.D. University of Cincinnati - Judith T. Feinberg, M.D.

Pennsylvania University of Pennsylvania - Harvey M. Friedman, M.D. University of Pittsburgh - John W. Mellors, M.D.

Rhode Island The Miriam Hospital - Timothy P. Flanigan, M.D.

Tennessee Vanderbilt University School of Medicine - David W. Haas, M.D.

Texas *University of Texas Medical Branch - Richard B. Pollard, M.D. University of Texas Southwestern Medical Center - Richard A. Koup, M.D.

Washington University of Washington - Ann C. Collier, M.D.

Puerto Rico University of Puerto Rico School of Medicine - Jorge L. Santana, M.D.