Research Sites Needed: CHAVI 014 Being Launched
An exciting study is being conducted by the Center for HIV/AIDS Vaccine Immunology (CHAVI): “CHAVI 014: Investigation of Gene Variants Associated with Resistance and Susceptibility to HIV-1 Infection in HIV-1 Exposed but Uninfected Individuals with Hemophilia A”. Consider becoming involved.
ATHN became aware of the study while participating in the inaugural meeting of the European Association of Haemophilia and Allied Disorders (EAHAD). The ATHN Project Review Panel, lead by Dr. Jeanne Lusher and composed of Drs. Judith Anderson, Jorge Di Paola, Madhvi Rajpurkar, Maggie Ragni, Harold Roberts and as well as Laurel McKernan, MSN RN encouraged ATHN to lend its assistance in recruiting U.S. sites. Likewise, the HTC Network Coordinating Committee and the UDC Working Group have independently confirmed the importance of the study.
The Center for HIV-AIDS Vaccine Immunology (CHAVI) is a consortium of universities and academic medical centers established by the National Institute of Allergy and Infectious Diseases (NIAID) Directed by Barton Haynes, MD, of Duke University. The Center's goal is to solve major problems in finding the enabling technology for HIV vaccine development.
In the late 1970’s and early 1980’s, up to 80% of patients with hemophilia A were infected with HIV-1 through the widespread use of contaminated clotting factor concentrates. Infection, however, was not universal among individuals with severe hemophilia. This may have been because of chance exposure to non-contaminated FVIII products; however, it is also possible that some individuals that received contaminated products may have been protected from HIV-1 infection. It is known that a mutation in the CCR5 gene, called CCR5Δ32, can be responsible for protection in some, but not all, exposed and uninfected individuals. The current protocol aims to identify a large number of gene variants that influence susceptibility or resistance to HIV infection among patients with hemophilia A through an international genome wide association study. The overall goal is to discover novel pathways and mechanisms of immune protection from HIV infection that can be of use for HIV vaccine development.
The CHAVI genetics team aims to collect up to 1000 specimens from participants with hemophilia A, who remain HIV-1 uninfected, despite repeated exposure to Factor VIII concentrate with a high likelihood of HIV-1 contamination. CHAVI has already recruited collaborators throughout Europe with clinics participating from England, Spain, Switzerland, Germany, Greece and Italy. From these clinics it is anticipated that 400-450 exposed and uninfected subjects will be studied. Thus, from the US approximately 550 to 600 subjects will be needed to complete the study.
CHAVI will reimburse participating sites on a per case contributed basis to conduct one blood draw of participants that fulfill the criteria for study entry. Participants desired for recruitment will be those exposed to contaminated cryoprecipitate from 1979-1984 and who are now alive and HIV negative. Based on available information, the CDC Division of Blood Disorders estimates that at least 18 HTCs are caring for 30 or more patients who may meet the inclusion criteria. Mike Soucie (jps9@cdc.gov) can provide a list of UDC participants at your center who were born before January 1, 1984, have moderate or severe hemophilia A and have tested HIV negative in the UDC making them potentially eligible for this study.
CHAVI representatives will be at the ATHN Data Summit in Chicago on July 31-August 1, 2008.
A one day organizational meeting is being planned in Durham, North Carolina during August to explain the protocol and plan for protocol implementation. You can access the NIH approved protocol on the CHAVI website www.chavi.org under “clinical protocols” and then scroll down and open “CHAVI 014”.
To indicate your interest in the study and to receive information regarding the organizational meeting, please contact Amanda Stemke, Project Manager at the Duke Human Vaccine Institute via phone at 919.684.6043 or email at amanda.stemke@duke.edu.
