| Clinical Trials |
The organization of the CHAVI research effort is constructed to translate the findings of the CHAVI Discovery Teams into vaccine candidates that can be rapidly evaluated in early phase clinical trials. The CHAVI has established the following clinical protocols to advance this effort.
CHAVI 001 – Host Immune Responses to HIV-1 Acute HIV-1 Infection
Patients with Acute HIV-1 infection (AHI) within 2-3 weeks of transmission are being recruited for study in the CHAVI RO-1 and in the Mucosal and Innate Immunity Discovery Teams' work currently underway in the CHAVI 001 protocol.
- CHAVI 001 clinical protocol
(version 2)
CHAVI 002 – Anti-HIV-1 Immune Responses in Exposed and Uninfected Subjects (EU’s) in London, UK and Entebbe, Uganda
The CHAVI 002 protocol is the study of characterized exposed and uninfected (EU) patients at St. Mary’s Hospital London and in Entebbe, Uganda to determine the presence of anti-HIV immune responses. This study has been approved and is currently underway.
- CHAVI 002 clinical protocol (version 2)
CHAVI 005 – Analysis of Host Response to HIV-1 in Autoimmune Disease Patients
The purpose of this study is to test a hypothesis for why broadly reactive neutralizing antibodies are predominantly absent during AHI. This protocol will screen patients with autoimmune diseases such as lupus or Anti-Phospholipid Antibody Syndrome who are co-infected with HIV in order to study the quality of anti-HIV neutralizing antibodies. The hypothesis is that patients with B cell tolerance defects will be able to make more robust anti-HIV antibody responses. This study has been approved and is currently underway.
CHAVI 007 – Partnership of CHAVI and HPTN 052 --A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 In Serodiscordant Couples
HPTN 052 is comprised of 9 global sites recruiting 1750 discordant couples and studying them for 5 years. Through this collaboration, CHAVI will work to determine the genetic and immunologic basis for resistance to HIV in discordant couples when exposure and resistance have been established.
CHAVI 008- Molecular Characterization of HIV-1 Neutralizing Antibody Breadth and Potency in Natural Infection
The purpose of CHAVI 008 is to collect peripheral blood specimens from patients chronically infected by HIV-1 to study the frequency and molecular basis of broad and potent antibody-mediated virus neutralization and viral mechanisms of antibody avoidance, as well as other aspects of the immunobiology or immunogenetics of HIV-1 infection pertaining to virus containment.
- CHAVI 008 clinical protocol (version 2)
CHAVI 009- Immunologic and Virologic Correlates of Maternal to Child Transmission of HIV-1 via Breast Milk
The CHAVI 009 clinical protocol will initially be a pilot study of ~80-100 HIV-infected pregnant women in rural Blantyre, Malawi with plans to become a larger prospective study. The purpose of this study is to define the immunologic and virologic correlates of breast milk transmission of HIV-1 in order to elucidate the mechanisms of viral transmission. The goal of this study is to improve antiviral immunity which can prevent the transmission of HIV from mother to child during breastfeeding.
CHAVI 010 - Understanding the Breadth and Specificity of HIV-2 Elicited Neutralizing Antibodies and Cellular Responses against HIV-2 and HIV-1 Proteins
The purpose of CHAVI 010 is to collect blood specimens from HIV-2 positive patients and HIV-1 and HIV-2 negative patients in order to identify the breadth and specificity of HIV-2 elicited neutralizing antibodies (Nabs) against primary single genome amplified (SGA) HIV-2 Env proteins. Investigators will identify what specificities of Nabs confer protection against HIV-2 and if comparable antibody specificities might be beneficial in an HIV-1 vaccine.
CHAVI 011 - Formative Research to Enhance Recruitment, Retention, Prevention Counseling, and Partner Notification Strategies for CHAVI 001
As an ancillary study of CHAVI 001, the purpose of the 011 is to facilitate implementation of CHAVI 001 studies by enhancing recruitment, retention, partner notification, and prevention counseling through the collection of formative research. The principal investigators of the 011 study are Dr. Catherine MacPhail at the Reproductive Health and HIV Research Unit at the University of the Witwatersrand in Johannesburg, South Africa and Dr. Irving Hoffman at the University of North Carolina Chapel Hill in Chapel Hill, North Carolina, USA.
CHAVI 012 - Mucosal and Innate Immune Responses, and Viral Reservoirs in Tissues and Cells During Acute HIV-1 Infection
The purpose of CHAVI 012 is to increase scientific knowledge through basic research on mechanisms of transmission, innate immunity, protective immune responses and host defense at the mucosal level to facilitate the development of vaccines to prevent and/or control mucosal HIV infection.
The purpose of CHAVI 014 is to prospectively obtain peripheral blood specimens from existing cohorts of HIV-1 exposed, yet uninfected patients with haemophilia A to study the genetic factors that may influence susceptibility and resistance to HIV-1 infection. The hypothesis is based on the finding that a minority of individuals with haemophilia A are HIV-uninfected despite exposure to donor FVIII concentrate products between 1979-1984, which are assumed to have a high risk of HIV-1 contamination given the high proportion of HIV-1 infections in persons with haemophilia treated during this time period or from known HIV-1 contaminated batches. Up to 25% of these HIV-uninfected individuals are homozygous for the protective CCR5D32 allele compared to a 1% frequency of homozygosity in the general population, demonstrating the importance of human genetic variation in resistance to HIV-1 infection, but explaining only a small proportion of these cases. Additional gene variants may contribute to resistance to HIV infection following blood-borne exposure. This study will try to identify additional human genetic variants that influence susceptibility or resistance to HIV infection and will compare results with those of previously obtained HIV-1-positive controls.
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