Completed Observational Clinical Trials

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 were recruited for study in the CHAVI RO-1 and in the Mucosal and Innate Immunity Discovery Teams' work in the CHAVI 001 protocol.

CHAVI 002 – Anti-HIV-1 Immune Responses in Exposed and Uninfected Subjects (EU’s) in London, UK and Entebbe, Uganda

The CHAVI 002 protocol was 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.

CHAVI 005 – Analysis of Host Response to HIV-1 in Autoimmune Disease Patients

The purpose of this study was to test a hypothesis for why broadly reactive neutralizing antibodies are predominantly absent during AHI. This protocol screened patients with autoimmune diseases, such as lupus or Anti-Phospholipid Antibody Syndrome, who were co-infected with HIV in order to study the quality of anti-HIV neutralizing antibodies. The hypothesis was that patients with B cell tolerance defects would be able to make more robust anti-HIV antibody responses.

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 1,750 discordant couples and studying them for 5 years. Through this collaboration, CHAVI worked to determine the genetic and immunologic basis for resistance to HIV in discordant couples when exposure and resistance had been established.

CHAVI 008- Molecular Characterization of HIV-1 Neutralizing Antibody Breadth and Potency in Natural Infection

The purpose of CHAVI 008 was to collect peripheral blood specimens from patients chronically infected with HIV-1 to study the frequency and molecular basis of broad and potent antibody-mediated virus neutralization and the viral mechanisms of antibody avoidance, as well as other aspects of the immunobiology or immunogenetics of HIV-1 infection pertaining to virus containment.

CHAVI 009- Immunologic and Virologic Correlates of Maternal to Child Transmission of HIV-1 via Breast Milk

The CHAVI 009 clinical protocol began as 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 was 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 was 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 was 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 identified the specificities of Nabs that conferred protection against HIV-2 and whether comparable antibody specificities may have been 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 was 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 were 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 was 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.3)

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

The purpose of CHAVI 014 was to prospectively obtain peripheral blood specimens from existing cohorts of HIV-1 exposed, yet uninfected patients with hemophilia A to study the genetic factors that may influence susceptibility and resistance to HIV-1 infection. The hypothesis was based on the finding that a minority of individuals with hemophilia 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 hemophilia 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 aimed to identify additional human genetic variants that influence susceptibility or resistance to HIV infection and compared the results with those of previously obtained HIV-1-positive controls.