This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this protocol is to determine whether early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of HIV-AIDS, non-AIDS, or death from any cause. Secondary Objectives include: a. To compare early ART to deferred ART for each component of the primary composite endpoint: ? AIDS or death from AIDS ? Non-AIDS or death not attributable to AIDS b. To compare early ART to deferred ART for the following secondary outcomes: ? All-cause mortality ? Non-AIDS ? CVD (myocardial infarction, stroke, coronary revascularizaton) ? ESRD (initiation of dialysis, renal transplantation) ? Decompensated liver disease ? Non-AIDS malignancy, excluding basal and squamous cell skin cancers ? Non-AIDS malignancy, including basal and squamous cell skin cancers ? AIDS ? Bacterial pneumonia ? Adverse events ? Hospitalization ? Quality of life ? Health-care utilization and cost of care ? HIV transmission risk behavior ? HIV drug resistance ? Pulmonary embolism or deep vein thrombosis ? New-onset diabetes mellitus ? Coronary artery disease requiring drug treatment ? Congestive heart failure ? Peripheral arterial disease ? Change in estimated GFR and development of proteinuria ? Blood pressure and blood lipids ? ECG abnormalities ? Use of blood pressure- or lipid-lowering treatment or aspirin
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