IAVI Protocols

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Protocol C: Follow-up of Incident Cases

This is a prospective, observational, multi-center study to evaluate laboratory, clinical, immunologic and viral markers of disease progression in recently HIV-infected volunteers. HIV disease progression will be evaluated in volunteers who have been recently infected with HIV. At the sites in Lusaka and Kigali, the spouses of the recently infected volunteers are studied to determine their immune response and how it relates to transmission of HIV. An understanding of the early stages of HIV infection (called ‘acute infection’) is critical. A better comprehension of how the virus and the human immune system interact early in infection as opposed to how they decline in immune response later on may better inform the development of experimental HIV vaccines.

Protocol G:

There are currently more than 30 studies in which vaccines against HIV-1 are being developed and/or tested. Of those trials, there have been two that attempted to prevent infection by using a vaccine to make the body produce antibodies. An antibody is a protein made by the immune system to fight off infection. Although neither of the two trials was effective, this study proposes that an ideal vaccine would cause the body to make special antibodies – broadly neutralizing antibodies (nAbs) – before being exposed to HIV. Protocol G is a cross-sectional study to screen for and generate broadly neutralizing monoclonal antibodies from HIV-infected individuals. It is known that this type of antibody is what makes vaccines against other viruses (polio, flu and measles) effective. However, HIV often mutates and so a combination of antibodies would need to be made by the body in order to protect it from infection. It is rare that an HIV-positive individual will have the nAbs, or the combination of antibodies, that would protect the body from getting the virus.

Protocol H:

Protocol H is a prospective, multi-center, observational study of volunteers who were enrolled in IAVI-affiliated trials and became HIV-infected in the course of the trial or within 24 months of the end of their study participation. The goal is to follow the clinical, laboratory, immunologic and virologic parameters at frequent intervals after HIV diagnosis.

Long-term non-progressors:

The study of long-term non-progressors evaluates the long-term health status of volunteers who are/have been volunteers in an HIV-vaccine clinical trial sponsored by IAVI. The primary objectives of this study are to conduct long-term follow-up and assess the long-term health status of HIV-vaccine clinical-trial volunteers. This includes the frequency of HIV infection in the volunteers as well as an examination of antibodies caused by the vaccine in volunteers who tested HIV-positive at the end of the IAVI vaccine trial. Lastly, laboratory tests are done on blood from the volunteers to study the virus and their immune responses.

DID YOU KNOW...


• Approximately 25 million Africans are HIV+ and 225 million adults are HIV- and married, at risk of acquiring HIV within their marriages.

•The U.S. government spends $2.2 billion annually – 10 percent of the entire U.S. bilateral foreign aid budget -- to provide antiretroviral therapy to 3 million Africans.

•Treating one ART patient over the course of 10 years costs about $7000.

•The World Health Organization (WHO) estimates that five new people are infected by HIV for every two who receive antiretroviral therapy (ART).