INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) is one of six HIV/AIDS clinical trials networks funded in 2006 by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health. Currently, INSIGHT is conducting studies in 36 countries worldwide.
INSIGHT consists of four international coordinating centres (ICCs) - CHIP is one of them.
The ultimate vision of INSIGHT is: “Reducing the global burden of HIV and other infectious diseases”. INSIGHT is in a position to respond rapidly to the challenges that endemic and emerging infectious diseases present through its globally-located investigators and its diverse sites that are poised to conduct research and quickly disseminate evidence-based clinical management strategies. INSIGHT’s mission is to: “To define optimal strategies for the management of HIV and other infectious diseases through a global clinical research network.”
INSIGHT is organized with an Executive Committee, primarily responsible for securing network funding that enhances and sustains the efficient and effective organization. The daily business is maintained through the Scientific Steering Committee (SSC) and the Operational Steering Committee (OSC). Jens Lundgren is chairing the SSC, with responsibility for ensuring outstanding research productivity within the INSIGHT network and identification and development of new research projects aligned with the INSIGHT mission. The Operational Steering Committee (OSC) is responsible for oversight of protocol teams; maintaining quality and performance and developing cross network procedures.
INSIGHT Executive committee members:
James D. Neaton (Chair)
Beverly L. Alston Smith
Waldo H. Belloso
David A. Cooper
Fred M. Gordin
H. Clifford Lane
Jens D. Lundgren
Robert C. Palmer
Trials run by the network:
FLU 002 & 003 details on trial
FLU 002 Plus (Respiratory Virus Outpatient Study, INSIGHT Protocol No. 002) opened in September 2009 as the H1N1v Influenza Study (FLU 002). The initial purpose was to describe participants in geographically diverse locations with influenza A - 2009 pandemic H1N1 (2009 H1N1) virus infection and their clinical course over a 14-day period following enrollment. In June 2011 the protocol was amended to include other types of influenza, including influenza A subtypes such as H3N2 and 2009 H1N1, or influenza B. In August 2013 the protocol was further expanded to include enrollment of participants with a suspected targeted non-influenza respiratory virus, e.g., MERS-CoV, in addition to those with suspected influenza.
FLU 003 Plus (Respiratory Virus Hospitalization Study, INSIGHT Protocol No. 003) opened in September 2009 as the H1N1v Hospitalization Study (FLU 003). The initial purpose was to consecutively enroll individuals locally diagnosed with influenza A who were hospitalized with complications or severe disease at times when pandemic 2009 H1N1 influenza virus was broadly circulating in their geographic area and to follow their clinical course over a 60-day period following enrollment. In June 2011 the protocol was amended to include enrollment of patients with a diagnosis of influenza (confirmed or suspected), irrespective of type or subtype, who are hospitalized with complications or severe disease. In August 2013, the protocol was further expanded to included participants with a suspected or confirmed diagnosis of a targeted non-influenza viral respiratory infection, e.g., MERS-CoV, in addition to confirmed or suspected influenza (of any type)
INSIGHT 006, the Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (FLU-IVIG), is an international randomized double-blind placebo-controlled trial of anti-influenza hyperimmune intravenous immunoglobulin (IVIG) in individuals hospitalized with influenza (flu) A or B, to determine whether, when added to standard of care (SOC) treatment, IVIG helps reduce the severity and duration of flu symptoms. FLU-IVIG is expected to enroll approximatedly 320 participants at up to 40 sites in the US, Europe, South America, and Australasia. Each participant is followed for approximately 28 days. The study is expected to enroll over multiple flu seasons in both the Northern and Southern Hemispheres.
START details on trial
INSIGHT's START (Strategic Timing of AntiRetroviral Treatment) is an international randomized trial to determine whether starting antiretroviral therapy (ART) early (before CD4 drops to less than 500 cells/mm³), rather than waiting until CD4 drops to less than 350 cells/mm³ (when evidence from randomized trials supports starting ART), reduces the occurrence of serious morbidity and mortality. START began enrollment in April 2009 and is currently being carried out at 222 clinics in 35 countries around the world. Enrollment was completed on 23 December 2013, with 4,688 participants
C.diff is an international observational study to estimate the 90-day response rates for several different antibiotic treatments for C. difficile infections in a cohort of solid organ and hematopoietic stem cell transplant patients. This includes treatment success, recurrence, and complications. Secondary objectives are to describe the clinical characteristics of C. difficileinfections and to assess risk factors for outcomes over a 90-day follow-up period.
Link to the INSIGHT website