ACTG Highlights

01 Clinical

A central mission of DIR is to develop new treatments. Dr. Lane and his
colleagues pioneered the clinical studies of ganciclovir for CMV retinitis, and recently
completed the first controlled clinical trial of foscarnet for the same disease, a trial that
clearly documents the drug's efficacy. Other NIAID DIR clinical researchers continue their
long-term studies of fungal, bacterial, viral, and parasitic diseases in patients not infected
with HIV. The progress made by these investigators augments the work being done by
those working with HIV-associated Ols.
In addition to conducting clinical trials for Ols, Dr. Lane and his colleagues have
led efforts to understand how one of the most important of these opportunistic infections.,
PCP develops. In one study, published in the Annals of Internal Medicine in 1988, they
found no evidence that Pneumocystis organisms set up a latent infection in the lungs. In
another study, also published in the Annals of Internal Medicine but one year later, they
found that CD4 cell counts of HIV-infected persons are predictive of who will develop
opportunistic pneumonias. They demonstrated that patients do not usually develop PCP
unless their T4 cell counts drop below 200. This information was used by the PCP Task
Force to develop guidelines that the Food and Drug Administration used to decide who
could benefit by using prophylactic aerosolized pentamidine. Dr. Lane and his colleagues
continue to characterize the disease processes underlying pulmonary problems in HIVinfected persons.
Division of Microbiology and Infectious Diseases
Because of the rarity of certain viral and fungal diseases, DMID several years ago
established two networks of clinical groups to conduct trials in these areas.
Antiviral Research Branch
Besides supporting preclinical research on viral opportunistic infections associated
with HIV, the Antiviral Research Branch (ARB) of NIAID's DMID also supports clinical
trials of experimental therapies for severe herpesvirus and papillomavirus infections. Some
diseases caused by these viruses--such as shingles, genital warts, and disseminated CMV--
are opportunistic infections seen in persons with AIDS.
Herpesvirus clinical trials are conducted by the Collaborative Antiviral Study Group
(CASG), directed by Richard J. Whitley, M.D., at the University of Alabama at
Birmingham. This multicenter group of 55 clinical investigators focuses on rare
herpesvirus infections that may not provide sufficient economic incentive for aggressive
industrial investment. The CASG interacts closely with the Food and Drug Administration
(FDA) and industrial drug sponsors in the planning and execution of the clinical trials.
This close communication helps ensure that the resultant data are both scientifically
significant and acceptable to the FDA for licensing purposes.

6