AIDS Clinical Testing Unit

Pelvic inflammatory disease Peripheral neuropathy

Category B conditions take precedence over Category A conditions.

Category C: for classification purposes once a category C complication has occurred, a person remains in category C.

Candidiasis of the bronchi, trachea, or lungs Candidiasis of the esophagus Cervical carcinoma, invasive Coccidioidomycosis, disseminated or pulmonary Cryptococcoses, extrapulmonary Cryptosporidiosis, chronic intestinal Cytomegalovirus Encephalopathy

Herpes simplex, chronic ulcers of longer than a month's duration Histoplasmosis, extrapulmonary or disseminated Isosporiasis, chronic intestinal Kaposi's sarcoma Lymphoma, primary brain Lymphoma, immunoblastic

Mycobacterium avium complex or Mycobacterium kansasii, disseminated or extrapulmonary Mycobacterium tuberculosis, any site Other Mycobacterium species, extrapulmonary or pulmonary Pneumocystis carinii pneumonia Progressive multifocal leukoencephalopathy Pneumonia, recurrent Salmonella septicemia, recurrent Toxoplasmosis of the brain Wasting syndrome due to HIV

In children below the age of 13 the following two illnesses are also used for Category C classification:

Multiple, recurrent bacterial infections Lymphoid interstitial pneumonia/pulmonary lym-phoid hyperplasia

AIDS Clinical Testing Unit The site at which AIDS drug trials are performed in the aids clinical trials group, a division of the national institute OF ALLERGY AND INFECTIOUS DISEASE (NIAID).

AIDS Clinical Trials Group (ACTG) Also known as AIDS Clinical Trials Unit (ACTU). A

nationwide, multicenter clinical trials network that tests new drugs and treatment strategies for adults and children infected with HIV that is sponsored and administered by the National Institute of Allergy and Infectious Diseases (NIAID). The ACTG was established by NIAID in 1987 and remains the largest network of its kind in the world. The specific goals of the ACTG are threefold: to evaluate innovative therapeutic strategies and interventions to control HIV infection and its complications; to facilitate rapid translation of basic research into clinical research and practice; and to provide a flexible resource for state-of-the-art, multidisciplinary clinical trials that address the goals and objectives of NIAID's therapeutics research agenda. NIAID contracts with institutions such as hospitals, academic medical centers, and so forth to perform the actual drug trials through a grant process, with a principal investigator controlling the trial.

The ACTG is an outgrowth of NIAID's first major programs for the evaluation of potential treatments for people with AIDS, which began in the summer of 1986. The original 36 AIDS Clinical Trials Units included two sites that enrolled children with AIDS. Additional pediatric sites were added between 1988 and 1989, and again in 1992. After a competitive renewal in 1992, the ACTG grew to include 35 adult and 22 pediatric AIDS Clinical Trial Units, in addition to a statistical and data analysis center and an operations office. More than 35,000 adults and 6,000 children and adolescents have enrolled in ACTG clinical trials ranging from early single-site safety studies to large-scale, multicenter efficacy trials.

In 1993, NIAID conducted a comprehensive evaluation of the ACTG to assess its mission, scientific agenda, and future direction, as well as the group's organizational structure and efficiency. This review was carried out by an external scientific review panel that evaluated the ACTG's scientific plans, and NIAID staff working group that assessed organizational and managerial issues. Both review groups recommended that the leadership of the ACTG be strengthened, giving it increased authority and accountability for development and management of its scientific program. The reviewers also recommended that the ACTG place greater emphasis on pathogenesis-based clinical research.

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