Scientists at nine U.S. medical centers are looking for possible benefits of giving short-term, daily doses of zidovudine (AZT) to people newly infected with HIV, the virus that causes AIDS, in a trial sponsored by the National Institute of Allergy and Infectious Disease (NIAID).
In particular, the trial focuses on whether AZT can delay the progression from primary HIV infection to the development of AIDS. Often described as an influenza-like illness, this early stage of infection usually occurs two to 12 weeks after the first exposure to HIV, while the virus reproduces rapidly in the body. Although the stage ends and the symptoms go away after several weeks, HIV remains and many years later can lead to full-blown AIDS.
Some 80 people older than 13 years will be enrolled in the trial, sponsored by the institute's Division of AIDS Treatment Initiative (DATRI) program. Originally begun at four sites in January 1993, the DATRI 002 trial has expanded to nine sites. These sites are Bellevue Hospital in New York, N.Y., Broward General Medical Center in Fort Lauderdale, Fl., Brown University in Providence, R.I., Cedars-Sinai Medical Center in Los Angeles, Calif., the Department of Veterans Affairs Medical Center in Palo Alto, Calif., Houston Clinical Research Network, Texas, Johns Hopkins School of Medicine in Baltimore, Md., Southwestern Medical Center in Dallas, Texas, and University of Illinois in Chicago. An original trial site, Massachusetts General Hospital in Boston has decided not to conduct the trial.
AZT is one of only three drugs approved by the Food and Drug Administration for use to delay the progress of HIV infection. The drug usually is not taken until HIV infection causes a significant decrease in the number of CD4+ T cells, white blood cells killed by the virus.
In the current trial, patients begin AZT therapy during primary HIV infection in an attempt to reduce the amount of rapidly reproducing virus and, perhaps, delay disease progression. Participants will randomly receive either 1,000 milligrams of AZT or a placebo daily for 24 weeks and then be followed to look for differences between the two groups. Specifically, the investigators will determine whether AZT slows the drop in CD4+ T cells, which health care workers monitor to gauge disease progression.
For someone at risk for HIV infection, flu-like or mononucleosis-like symptoms may indicate that the early, primary stage of HIV infection is under way," says Manette T. Niu, M.D., medical officer of the study in NIAID's Division of AIDS.
Primary HIV infection is a complex illness that can have many symptoms, Dr. Niu explains. Almost all patients report a moderate to severe fever. Also, patients may experience other symptoms including rash, swollen lymph nodes, sore throat, muscle and joint aches, diarrhea, nausea, vomiting, severe headaches and mouth ulcers. These symptoms usually disappear without specific treatment, Dr. Niu says, even though patients remain infected with HIV.
Such symptoms are important warning signs of HIV infection for those at high risk because conventional HIV blood tests, which look for antibodies, cannot detect infection during the initial weeks," Dr. Niu explains. "People don't form antibodies to HIV until two to six months after infection -- some weeks after the early, primary infection period."
During enrollment screening, trial investigators are checking would-be participants with a blood test that looks for a protein part of HIV called p24. High, measurable levels of this protein usually are present in the blood during the first six weeks of HIV infection.
The trial is sponsored by DATRI, a program established by NIAID in the fall of 1991, to support a clinical trials network that performs rapid, early-phase trials of potential therapies for HIV infection and associated opportunistic infections and cancers.
For more information on this or related studies, call 1-800-TRIALS-A (1-800-874-2572) from 9 a.m. to 7 p.m., ET. All calls are confidential.
NIAID, a component of the National Institutes of Health, supports investigators and scientific studies at universities, medical schools, hospitals and research institutions in the United States and abroad aimed at preventing, diagnosing and treating such illnesses as AIDS, tuberculosis, allergies, and asthma. NIH is an agency of the U.S. Public Health Service, part of the U.S. Department of Health and Human Services.