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

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000065-48
Application #
8166579
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2009-12-01
Project End
2010-06-30
Budget Start
2009-12-01
Budget End
2010-06-30
Support Year
48
Fiscal Year
2010
Total Cost
$726
Indirect Cost
Name
Virginia Commonwealth University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
105300446
City
Richmond
State
VA
Country
United States
Zip Code
23298
Holkova, Beata; Yazbeck, Victor; Kmieciak, Maciej et al. (2017) A phase 1 study of bortezomib and romidepsin in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, indolent B-cell lymphoma, peripheral T-cell lymphoma, or cutaneous T-cell lymphoma. Leuk Lymphoma 58:1349-1357
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Al Hawaj, M A; Martin, E J; Venitz, J et al. (2013) Monitoring rFVIII prophylaxis dosing using global haemostasis assays. Haemophilia 19:409-14
Noureddin, Mazen; Yates, Katherine P; Vaughn, Ivana A et al. (2013) Clinical and histological determinants of nonalcoholic steatohepatitis and advanced fibrosis in elderly patients. Hepatology 58:1644-54
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