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The Collaborative Antiviral Study Group (CASG) is a multi-institutional collaborative network funded by the National Institute of Allergy and Infectious Diseases (NIAID) to conduct clinical trials to evaluate experimental therapies for viral infections. It is comprised of investigators at approximately 50 clinical research institutions and a Central Unit that serves as the core administrative, research, laboratory, biostatistical and data management component of the CASG. The CASG infrastructure makes it possible to respond expeditiously to promising new therapies as well as unanticipated emergent clinical priorities. The CASG is programmatically managed by the Virology Branch, Division of Microbiology and Infectious Diseases, NIAID.

The CASG interacts closely with its own advisory committees to establish research priorities and direction. Through ongoing dialogue with potential industrial sponsors, the CASG has established a collegial foundation for industry-academia-government collaborations, which facilitate the successful implementation of CASG-sponsored trials. The CASG often collaborates with the Adult AIDS Clinical Trials Group.

CASG Research Agenda

The CASG was established in 1986 by NIAID to conduct clinical trials to evaluate experimental therapies for severe herpesvirus infections, such as herpes encephalitis, herpes zoster, neonatal herpes and symptomatic congenital cytomegalovirus (CMV) infections. The CASG's mandate was expanded in 1995 to include a broad range of medically important viral infections, including hantavirus, human papillomavirus, respiratory viruses, enteroviruses, and hepatitis viruses. The CASG evaluates therapies for the treatment of acute and chronic viral infections. These include head-to-head comparisons of approved versus new drugs, drug combinations using drugs from different manufacturers, studies designed to gain approval for a new indication, treatments for rare infectious diseases, and treatments for difficult populations (e.g. neonates, immunocompromised patients). The group's goal is to conduct clinical trials of experimental therapies that will support new drug application approval by the Food and Drug Administration.

Examples of adult clinical trials:

• Acyclovir (ACV) versus BV-araU for localized herpes zoster.
• Ribavirin for hantavirus pulmonary syndrome.
• Zanamivir for influenza.
• Ribavirin for respiratory syncytial virus infection in bone marrow transplant recipients.

Examples of pediatric clinical trials:

• Ganciclovir for symptomatic congenital CMV infection.
• CMV monoclonal antibody for non-central nervous system (CNS) symptomatic congenital CMV.
• ACV suppressive therapy for neonatal herpes simplex virus (HSV) infection limited to the skin, eye and mouth.
• ACV suppressive therapy for neonatal HSV infection involving the CNS.
• Cidofovir for recurrent respiratory papillomatosis.

Studies under development include evaluations of therapies for the treatment of hepatitis C virus and enteroviral infections in children, and hepatitis B virus infection in HIV-infected and uninfected adult patients.

Accessing These Resources

Investigators or industrial sponsors wishing to collaborate with the CASG should refer to the CASG research agenda above to determine whether the therapeutic concept is likely to be of interest to this group. If so, they should discuss their concept with the CASG Project Director, Dr. Richard Whitley at the University of Alabama, Birmingham, AL (phone: 205-934-5316).