Subset analysis.In addition to the primary study question, SMART will generate data for subset analysis on quality of life, cost effectiveness, HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. transmission risk behavior, and probably metabolic complications. Data for a given subset analysis will be gathered only from those sites preselected for the particular question. 1) Quality of life. Antiretroviral therapy can suppress viral load viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. and raise CD4 T cell Noun 1. CD4 T cell - T cell with CD4 receptor that recognizes antigens on the surface of a virus-infected cell and secretes lymphokines that stimulate B cells and killer T cells; helper T cells are infected and killed by the AIDS virus counts; however, treatment often produces side effects Side effects Effects of a proposed project on other parts of the firm. and toxicity (e.g. nausea, diarrhea, neuropathy, etc.) that decrease quality of life. Therefore, quality of life may decline after the initiation of treatment for the patient with early, asymptomatic disease. This subanalysis will examine the long-term impact of early versus deferred initiation of therapy and the stage of HIV disease on quality of life. It will also examine the impact of uninterrupted versus episodic therapy on quality of life. 2) Cost. The treatment of HIV disease is expensive and antiretroviral drugs Antiretroviral Drugs Definition Antiretroviral drugs inhibit the reproduction of retroviruses—viruses composed of RNA rather than DNA. The best known of this group is HIV, human immunodeficiency virus, the causative agent of AIDS. are a large part of the cost. However, the treatment of opportunistic infections Opportunistic infections Infections that cause a disease only when the host's immune system is impaired. The classic opportunistic infection never leads to disease in the normal host. , which may require hospitalization, is also expensive. If a treatment approach reduces the use of antiretrovirals but raises the number of infections, it could be more costly in the long run than using more antiretrovirals. This subanalysis will examine the treatment costs of SMART's 2 arms. 3) HIV transmission risk behavior. With reports of drug resistance among persons with acute HIV infection, attention has focused on the role that HIV-infected patients under care play in the ongoing transmission of HIV. This subanalysis will examine the effect that deferring or discontinuing therapy has on HIV transmission risk behavior and the effect of viral load on risk behavior. 4) Metabolic complications. The metabolic complications of antiretroviral therapy, including a potentially increased risked for cardiovascular disease and changes in body habitus habitus /hab·i·tus/ (hab´i-tus) [L.] 1. attitude (2). 2. physique. hab·i·tus n. pl. , may be severe enough to warrant delay in the start of therapy. This subanalysis will evaluate the effect of the 2 treatment strategies on the development of metabolic complications. An examination of metabolic complications may be structured as an actual substudy, but a final decision whether to run a subanalysis or substudy had not been made at press time. |
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