"We have very little information about the early stages of HIV infection," says Richard Chaisson, M.D., associate professor of medicine and director of the Johns Hopkins AIDS Service. Chaisson is a co-investigator for the project, which is led by Joseph B. Margolick, M.D., Ph.D., associate professor of molecular microbiology and immunology at the Johns Hopkins School of Public Health.
"Most people who are HIV-positive don't even know it until they are tested for the virus years after becoming infected," notes Chaisson.
The study will measure how effectively combination drug therapy works during the early stages of infection with HIV. In combination therapy, newly developed anti-HIV drugs called protease inhibitors are combined with older drugs, such as AZT and ddI, to give a double punch against the AIDS virus.
The researchers want to learn if early, aggressive, combination therapy only reduces or actually eliminates HIV from the body. The researchers also hope to determine how long anti-HIV drugs need to be taken for maximum benefit. "We'd like to know whether we can reduce the damage caused by HIV infection if we start treatment early," says Chaisson.
Another important goal is to determine how early HIV infection affects the activity of two important chemicals that help stimulate the immune system--interleukin-2 (IL-2) and interleukin-12 (IL-12). IL-2 and IL-12 stimulate the growth and functions of the immune system cells that HIV-1 kills, according to Margolick.
"We are going to treat some of the patients with IL-2 to see if we can repair some of the damage the virus does to helper T cells during the first few months of infection," Margolick says. Helper T cells are white blood cells that regulate the immune system's response to infection. They are a major target of the AIDS virus.
The study will recruit up to 50 individuals in the first year, primarily intravenous drug users, who were infected within six months of entering the program.
Other institutions participating in this project include the University of Pittsburgh and Cornell University Medical College (New York, N.Y.).
The Hopkins study is one of several being done across the country. Other institutions conducting similar studies include the University of California, San Francisco; University of Alabama; University of Colorado; University of Washington; and the Aaron Diamond Center (New York, N.Y.).
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