Subset Analyses

In addition to the primary study question, SMART will generate data for subset analyses on quality of life, cost effectiveness, HIV 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.

Quality of life. Antiretroviral therapy can suppress viral load and raise CD4 T cell counts; however, treatment often produces side effects 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.

Cost. The treatment of HIV disease is expensive and antiretroviral drugs are a large part of the cost. However, the treatment of opportunistic infections, 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.

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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.

Metabolic complications. The metabolic complications of antiretroviral therapy, including a potentially increased risked for cardiovascular disease and changes in body habitus, may be severe enough to warrant a 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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