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ARRA Investments in HIV/AIDS: Comparative Effectiveness Research

Public Health Burden
Although progress has been made in the global fight against HIV/AIDS, the epidemic continues to devastate the United States and the international community with 56,300 new HIV infections each year in the United States and an estimated 33 million people living with HIV worldwide. As highly active antiretroviral therapy has dramatically reduced mortality among those with HIV, disease management of HIV and other co-morbidities is increasingly complex. There are currently more than 150 different treatment regimens based on approved antiretroviral drugs, and many patients are using additional treatments to address various AIDS-related co-morbidities, co-infections, and chronic diseases.

Comparative Effectiveness Studies
Comparative effectiveness studies compare the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions. Such studies can provide information on the relative strengths and weaknesses of various medical interventions and help clinicians and patients make treatment decisions. ARRA funds will be used for several studies of HIV/AIDS treatment, including the following:
  • Several projects will use data from the Multicenter AIDS Cohort Study (MACS), a longitudinal study, started in 1983, of a highly representative cohort of men with, or at high risk for, HIV infection. These projects will collect additional laboratory markers, which will be combined with the MACS longitudinal epidemiologic and clinical database to allow evaluations of cardiovascular, neurocognitive decline, metabolic changes and malignancy outcomes for men receiving different treatment regimens.1 A systematic examination of the identity, quantity and diversity of microbes that reside in and translocate from the intestinal lumen will add to our understanding of systemic immune activation shown to correlate with the rate of disease progression.2 The quantification of the blood levels of various markers of inflammation may help identify underlying predictors of disease and how to best modulate their impact. 3
  • Other projects will use epidemiological and clinical data from the Women’s Interagency HIV Study (WIHS), a longitudinal study founded in 1993 of a highly representative cohort of women with, or at high risk for, HIV infection. For example, the comparison of novel markers of immune activation and inflammation between populations of women who are HIV negative, HIV positive yet controlling disease progression (elite controllers), HIV positive on effective therapy, and HIV positive with a poor response to therapy or those women followed before the advent of therapy will evaluate the predictive value of different markers of disease in order to facilitate disease management. 4
  • One project will assess the efficacy of male circumcision for prevention of Human Papillomavirus (HPV) infection in high risk men and in their female partners. The project will use already collected specimens from a trial that showed that male circumcision reduced HIV infection by 60-70 percent. Control of HPV, the cause of nearly all cervical cancer in women and penile cancer in men, would greatly reduce morbidity and mortality from these cancers. 5
Databases for Comparative Effectiveness Research
Comparative effectiveness research relies on the availability of large datasets, clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data. To lay the basis for future comparative effectiveness research, ARRA funds are supporting the development or expansion of various datasets, such as the following:
  • One project will aims to determine the incidence, risk factors, and cause-specific mortality of major cardiovascular disease, chronic kidney and end stage renal disease, and of non-AIDS-defining malignancies for persons with HIV. Existing clinical records from the 80,000 HIV-infected individuals participating in the North America AIDS Cohorts Collaboration on Research and Design (NA-ACCORD) is the largest HIV collaborative cohort in North America, with multi-year longitudinal clinical data on over 80,000 HIV-infected individuals followed at HIV clinical care and research sites. Behavioral factors and clinical data regarding each co-morbidity will be captured from existing clinical records and a virtual repository to support research on early biomarkers will be created. 6
  • Another project would expand sample collection at the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) to complement the available clinical data and allow for comparison of outcomes related to HIV disease and treatment among a well distributed and diverse population of HIV-positive patients in the U.S. 7

  1. 5U01AI35043-17 -- Center for Analysis and Management of MACS (CAMACS) -- Jacobson, Lisa (MD)
  2. 2U01AI35039-17S1 -- Multicenter AIDS Cohort Study (MACS)-Chicago Consortium -- Phair, John and Wolinsky, Steven (IL)
  3. 2U01AI35042-17 -- Multicenter AIDS Cohort Study (MACS)-Baltimore Consortium -- Margolick, Joseph (MD)
  4. 5U01AI34993-16 -- Women’s Interagency HIV Study (WIHS) IV -- Chicago Consortium Cohen, Mardge (IL)
  5. 5U01AI75115-03S1 -- Adult Male Circumcision: HIV/STIs and Behaviors in a RCT and Post RCT Surveillance in Rakai -- Gray, Ronald (MD)
  6. 5U01AI69918-04S1 -- IeDEA North America (NA-ACCORD) -- Moore, Richard (MD)
  7. 5R24AI67039-04S1 -- Center for AIDS Research (CFAR): R24 for CFAR-Network of Integrated Clinical Sciences, CNICS -- Saag, Michael (AL)

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