HIV is the acronym for the human immunodeficiency virus. HIV is a retrovirus that destroys CD4 cells in the human body. CD4 cells are often referred to as the body’s ‘army’, as these cells help regulate the immune system. As a result of HIV destroying the CD4 cells, the immune system becomes compromised. Once infected, a person may not exhibit symptoms for 8 to 10 years. HIV acquisition can lead to acquired immunodeficiency syndrome (AIDS). The latest HIV incidence data released by the Centers for Disease Control and Prevention (CDC) indicate HIV and AIDS remain a persistent problem worldwide and within the United States.
Approximately 33.3 million people worldwide are living with HIV and AIDS. A majority of infections do occur in less developed countries, often where our military forces deploy. Within the U.S., HIV incidence has remained stable at 50,000 new infections per year. From 2007 to 2010, there were ~ 53,200 infections in 2007; 47,500 infections in 2008; 45,500 in 2009; and 47,500 in 2010 (source: CDC and Prevention). At the end of 2011, approximately 1.2 million people in the U.S. were living with HIV. Among this group, ~ 14% did not know they were infected.
The clinical consequences of HIV infection have dramatically changed since the introduction of treatment with highly active antiretroviral therapy (HAART) in 1996. While AIDS, opportunistic infections (OI), and death remain the most serious consequences, rates of these complications have declined markedly and are no longer the primary concern for people to enter care early and start treatment.
HIV and the US Military
Members of the U.S. military represent a unique opportunity to study HIV disease. HIV infection in the military is similar to HIV infection in the U.S. in that the virus disproportionately affects younger and more active populations to include African Americans, Hispanics and Latinos, Asian and Pacific Islanders, and men who have sex with men (MSM). However, the HIV epidemic in the military sector differs from the epidemic in the general population in that active duty (AD) service members (SM) have free access to health care and medications and on average have fewer social and economic barriers that prevent good medical care. Despite active HIV prevention programs to include routine HIV screens of all SM every two years (since 2004), there are approximately 350 new HIV infections in the U.S. DoD population per year. HIV infected troops typically remain healthy and continue to serve on active duty; however, in spite of successful treatment with HAART, many develop serious non-AIDS (SNA) events including neurocognitive disorders, cardiovascular diseases, renal diseases, and cancer.
Scientific Strategic Aims
IDCRP is focused on current concerns for HIV infected military members, their care providers, and their commanders. The scientific strategic aims are as follows:
- Mitigate specific complications of HIV and highly active antiretroviral therapy (HAART) among military HIV-infected patients
- Identify, treat and prevent HIV-associated neurocognitive disorders (HAND) in the US military health care system
- Identify, treat and prevent serious non-AIDS in the U.S. military health care system
- Develop and employ predictive models to optimize individual management of HIV
- Improve therapeutic outcomes with the ultimate goal of functional cure of HIV infection
- Assess acquisition among HIV-infected active duty troops and how to prevent new infections
Benefitting from the unique racial/ancestral balance of the Military cohort (approx 45% European American, 45% AfricanAmerican, 8% Hispanic) as well as a setting with open access to healthcare, free medications, generally stable income, very low injection drug use, and a high level of education, this resource allows the program to address goals including 1) improving outcomes through understanding of factors associated with HIV infection and its treatment as well as complications of these, 2) understanding the safety and efficacy of non-HIV vaccine strategies important to the HIV-infected military and other relevant populations, and 3) understanding factors associated with HIV co-infections including STI and bidirectional effects on disease manifestations and progression.
IDCRP-000: DoD HIV Natural History Study (NHS)
The HIV NHS protocol and sub-analyses constitute the core of the IDCRP HIV Research Program. The NHS is an ongoing, longitudinal, observational cohort study designed to collected retrospective and prospective data with the United States (U.S.) military active duty and Department of Defense (DoD) health care beneficiary HIV infected population. Data collected and tissue samples contained within the U.S. Military HIV Natural History Study Repository (NHSR) represent a unique national scientific resource. The NHSR is an invaluable resource. The NHS has been instrumental in the growth of knowledge concerning how to prevent, diagnose and treat HIV and AIDS. This study dates back to 1986 when it began and has continued since that time.
IDCRP-008: Immune Reconstitution Syndrome (IRIS) Study
In collaboration with the Military HIV Research Program (MHRP), the IRIS study is an international observational cohort being conducted in Thailand, Kenya and the U.S. to evaluate the predictors, incidence, clinical presentation and immunopathogenesis of IRIS. IRIS is a serious diagnosis that develops due to worsening of infectious and non-infectious diseases shortly after antiretroviral therapy (ART) initiation. After starting treatment, these patients experience an excessive inflammatory response. The syndrome primarily has been observed in HIV+ patients who begin treatment at low CD4 levels and who have existing opportunistic infections; however, the exact etiology of IRIS is unclear.
IDCRP-016: Prevalence and Predictors of Neurocognitive Impairment Study
The neurocognitive impairment study is an observational pilot study with the objective to determine the prevalence of neurocognitive impairment within the active duty HIV+ military population. Neurocognitive impairment remains a major concern for those infected with HIV on and off treatment. HIV-associated neurocognitive disease (HAND) has been one of the main reasons cited that restricts active duty from piloting aircraft, personal reliability program positions (i.e. nuclear missile launch) and deployment. This was the first military study comparing neurocognitive impairment between active duty HIV-infected and HIV-uninfected groups, now being continued through a larger protocol – the ALLHANDS DoD study described below.
IDCRP-038: Strategic Timing of AntiRetroviral Treatment (START) Study
The Strategic Timing of AntiRetroviral Treatment (START) trial is an international, multi-site trial, designed to answer the question, “When should HIV treatment with medicines be started?” Although current recommendations suggest beginning treatment as soon as possible, there are risks and benefits for both starting treatment early versus later. This study seeks to investigate differences in the risk of acquiring serious illnesses and AIDS between groups that begin treatment at CD4+ counts above 500 cells/mm3 or at CD4+ counts below 350 cells/mm3.
IDCRP-063: Rifaximin Study
The Rifaximin Study is a randomized control trial investigating the effects of oral Rifaximin on gut microbial translocation. Bacteria in the gut are one of the suspected causes of chronic immune activation observed in HIV-infected individuals that remains even with modern therapies. This study seeks to determine whether Rifaximin treatment reduces levels of markers of immune system activation.
IDCRP-078: ALLHANDS DoD Study
ALLHANDS DoD is an observational study seeking to understand the natural history of HIV-associated neurocognitive disease (HAND). The study is being conducted in conjunction with the National Institute of Health’s (NIH’s) similar ALLHANDS study. ALLHANDS DoD and ALLHANDS NIH studies follow HIV-infected and HIV-uninfected individuals over 5 years. Two important aims of this study are to validate a neuropsychological test to identify those presenting with HAND and identify markers of immune activation in the central nervous system – a possible reservoir for latent HIV infection.
- Generate evidence to support DoD clinicians and Service-specific HIV Programs in the care of HIV-infected service members/retirees
- Define incidence and impact of HIV-associated neurocognitive disorders among HIV-infected service members
- Define incidence, impact, and develop prevention strategies for sexually transmitted co-infections among HIV-infected service members
- Domestic clinical partner complementing US Military HIV Research Program (MHRP) initiatives
Partners and Collaborators
The IDCRP HIV research program is primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID). The program is complementary to other DoD HIV research and surveillance efforts.
- Department of Defense HIV/AIDS Prevention Program
- Division of AIDS (DAIDS), NIAID, NIH
- Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF)
- International Network for Strategic Initatives in Global HIV Trials (INSIGHT)
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health (NIH)
- NIH AIDS Information
- Uniformed Services University of the Health Sciences (USU)
- U.S. Department of Defense Global Emerging Infections Surveillance and Response System (DoD-GEIS)
- Walter Reed Army Institute of Research (WRAIR)