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ARRA Investments in Stopping the HIV Pandemic


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 U.S. and an estimated 33 million people living with HIV worldwide. Of the ~1.1 million individuals living with HIV in the United States, 21 percent are unaware of their infection.

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), is advancing a three-pronged research approach for HIV prevention that potentially could curb the global pandemic: providing antiretroviral medicines to individuals who are not infected with HIV but who are at high-risk of becoming infected (pre-exposure prophylaxis), examining the feasibility of a universal, voluntary, annual HIV testing with immediate antiretroviral therapy for people who test positive for HIV infection (a “test and treat” approach), and identifying and understanding the latent reservoirs of HIV that are not affected by antiretroviral therapy. A significant number of ARRA awards are supporting research efforts to stop the AIDS/HIV pandemic. ARRA-funded projects that are part of NIAID’s three-pronged approach are described below.

Pre-Exposure Prophylaxis (PrEP)
The first component of this strategy consists of testing whether antiretroviral drugs can prevent HIV infection in people at high risk for acquiring the virus. This approach is known as pre-exposure prophylaxis, or PrEP. ARRA funds have accelerated recruitment for an ongoing Phase III PreP clinical trial:
  • The PreExposure Prophylaxis Study (iPrEx) includes 3,000 participants at national and international sites.1
Universal, voluntary HIV testing with immediate treatment for people who test positive for HIV infection: the “test and treat” approach
The second component of this strategy involves evaluating the feasibility of universal, voluntary HIV testing and immediate treatment for those who test positive, a strategy referred to as “test and treat.” In the June 10, 2009, issue of the Journal of the American Medical Association, NIAID leadership outlined a research path to address the question of whether a global program of universal, voluntary, annual HIV testing would effectively extinguish the HIV pandemic. This concept is believed to have the potential to reduce the rate of new infections from 20 to less than one person per 1,000 people per year. ARRA funds are being used to accelerate the pace of research in two clinical studies addressing the fundamental question “Can we develop methodologies to identify the highest risk populations and enroll them in clinical trials?”:
  • HPTN 064 (ISIS) –Multi-site prospective observational study of high-risk U.S. women to estimate overall HIV-1 incidence.2,3 This study will assess preferred recruitment strategies and explore barriers to testing.
  • HPTN 061 (BROTHERS) – This study is evaluating the feasibility and acceptability of a multifaceted community-level intervention for HIV prevention for U.S. black men who have sex with men (MSM). 4,5,6
Finding a Cure
The third component involves research to understand how HIV establishes and maintains latent pockets of virus; this information will be used to try to develop ways to control and eliminate these reservoirs of latent virus, potentially curing people of HIV. A new Program Announcement was published in Spring, 2009, soliciting applications to investigate basic mechanisms of latency and persistence and use this information to create models and assays that can be used to develop and evaluate methods to eradicate the reservoirs. In addition, grant supplements were awarded to jumpstart research on HIV latency. Some examples of ARRA-funded projects include:
  • Studies of the basic mechanisms that regulate the induction, maintenance and reactivation of HIV latency 7
  • Developing new therapies using cells from HIV-infected patients that can clear latent infection without enhancing new infection 8
  • Projects examining whether bone marrow is an important reservoir for cells latently infected with HIV9, or systematically exploring the whole body for latent viral reservoirs10



  1. 3U01AI064002-05S1 -- Chemoprophylaxis for HIV prevention in men -- Grant, Robert (CA)
  2. 5U01AI069504-03 -- CPCRA Clinical Trials Unit -- Gordin, Fred (DC)
  3. 5U01AI069423-03 -- University of North Carolina AIDS Clinical Trials Unit -- Eron, Joseph (NC)
  4. 5U01AI069503-03-- CPCRA Clinical Trials Unit -- Gordin, Fred (DC)
  5. 5U01AI069424-03 -- UCLA AIDS Prevention and Treatment Clinical Trials Unit -- Currier, Judith (CA)
  6. 5U01AI69480-02 -- Clinical Trials Unit for HIV Prevention & Microbicide Research -- Mayer, Kenneth (MA)
  7. R21AI0084711-01 -- A New Insight into HIV-1 Latency Through a Novel In Vitro System -- Romerio, Fabio (MD)
  8. U19AI082608-01 -- Innovative Therapies to Eliminate Persistent HIV Infection -- Margolis, David (NC)
  9. R0AI051192-06W1 -- Molecular Mechanisms of HIV Disease Pathogenesis -- Collins, Kathleen (MI)
  10. RC1AI086182-01 -- Virus Production from HIV Reservoirs -- Mullins, James (WA)


 
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