A new multicenter study will determine if monitoring levels of HIV, the virus that causes AIDS, in a person's blood can keep patients healthier longer by helping doctors make better treatment decisions. The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is recruiting 1,100 HIV-infected people through the NIAID-supported Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), a community-based clinical trials network.
CPCRA study 036 is comparing two strategies for deciding when to change anti-HIV therapy: 1) current clinical practice alone (monitoring the development of or changes in HIV symptoms as well as blood levels of CD4+ T cells, immune cells destroyed by HIV) versus 2) current clinical practice plus periodic tests measuring the amount of HIV, or viral load, in a given amount of blood.
Scientifically and medically, this is an extremely important study that addresses a major gap in knowledge," comments Anthony S. Fauci, M.D., NIAID director.
Although doctors commonly change a patient's antiretroviral therapy when drug efficacy appears to wane, they need better tools for deciding when such changes might be most beneficial. A new technology that detects blood levels of HIV RNA, the genetic material of HIV, has been suggested as a promising way for clinicians to both gauge the effectiveness of therapy and predict when the disease might get worse.
While many people believe that changes in the level of HIV RNA are good indicators of drug effectiveness, this has never been proven. This study will determine whether use of this expensive technology makes a difference in the quality of a patient's life," says Jack Killen, M.D., director of NIAID's Division of AIDS. It is not known, for example, if keeping HIV burden at a minimum with available therapies will have any clinical benefit, or if switching treatments more frequently will result in drug choices being exhausted too quickly.
The CPCRA study team has chosen to use the branched DNA (bDNA) assay for HIV-1, one of several new research tests that measure HIV viral load. The assay yields reproducible results and is relatively simple to perform. It uses a light-detecting system to find HIV RNA in virus particles in a blood sample. The intensity of light generated by the captured particles is proportional to the amount of HIV RNA present. The assay is made by Chiron Corp. of Emeryville, Calif., which, along with Smith Kline Beecham Clinical Laboratories of Philadelphia, is underwriting some of the technical costs of the study.
Volunteers in CPCRA 036 will be divided at random into two groups of 550 each--a current clinical practice (CCP) arm and an HIV RNA arm. Those in the CCP arm will be taken care of according to current clinical practice. Those in the HIV RNA arm will have bDNA assays performed at least every four months throughout the study, and clinicians will use the results of these tests in addition to current clinical practice to manage the care of these patients.
CPCRA 036 does not dictate the use of specific drugs or clinical strategies. Decisions about preventive and therapeutic drug regimens will be decided by the study volunteers in consultation with their doctors.
The point of using the bDNA assay is to improve doctors' efforts to keep HIV load as low as possible for as long as possible. Hence, study clinicians will get state-of-the-art updates about HIV RNA quantitation and are expected to aggressively manage patients in the HIV RNA arm based on this information.
To be eligible for CPCRA 036, a person must be HIV-infected and in reasonably good health, 13 years of age or older, have a CD4+ T cell count of 300 or fewer cells per cubic millimeter of blood 16 weeks prior to randomization, and receive their care from a participating CPCRA site.
Melanie A. Thompson, M.D., of the AIDS Research Consortium of Atlanta serves as the study chair, and George Perez, M.D., of the North Jersey Community Research Initiative in Newark is the study co-chair.
A list follows of all the CPCRA sites expected to participate in the study. To obtain contact telephone numbers at these sites, call the AIDS Clinical Trials Information Service at 1-800-TRIALS-A (1-800-874-2572).
NIAID, a component of the National Institutes of Health, supports research aimed at preventing, diagnosing and treating illnesses such as AIDS, tuberculosis, asthma, and allergies. NIH is an agency of the U.S. Public Health Service, part of the U.S. Department of Health and Human Services.