GHESKIO (Haitian Study Group for Kaposi's Sarcoma and Opportunistic Infections) in Port au Prince, Haiti is applying as a single site clinical trials unit (CTU) affiliated with two networks, the HVTN and the ACTG. The leaders of the two networks have strongly endorsed GHESKIO's participation. The GHESKIO Centers is a nongovernmental organization dedicated to research, clinical services, and training in HIV/AIDS. Haiti has the highest rates of HIV/AIDS in the Western Hemisphere with -4% of the adult population infected with Clade B HIV-1. Heterosexual transmission predominates with a male to female ratio of 1 to 1. GHESKIO has received 22 years of uninterrupted NIH support including an NIH Merit Award and has over 70 peer-reviewed publications. GHESKIO investigators have conducted landmark clinical trials on the treatment and prophylaxis of HIV-infected patients with tuberculosis and coccidia co-infection. The Haitian Government has designated GHESKIO a "Public Utility", a status reserved for institutions which are essential to the "welfare of the Haitian people", such at the Red Cross. Dr. Jean William Pape is the Principal Investigator of this proposal. He is the Director of GHESKIO, Professor of Medicine at Cornell University, and a member of the US Academy of Science's Institute of Medicine. Dr. Pape is on the ACTG Scientific Steering Committee and is Co-chair of the HVTN Efficacy Trials Working Group. The GHESKIO CTU will continue long-standing collaborations with investigators from Cornell and Vanderbilt Universities. GHESKIO has been a member of the HVTN since 1997 and the ACTG since 2002. It has established the infrastructure and procedures to conduct highest quality clinical trials. GHESKIO recruits volunteers for HIV/AIDS trials from on-site clinics, where 23,000 patients receive HIV voluntary counseling and testing annually. The population is of African descent, -70% female and ~ 25% adolescent. The CTU will provide oversight and centralized clinical research functions such as laboratory, data management, pharmacy, counseling, administration, and finance for the HVTN and ACTG cores and six transition protocols. In 2006-2007, GHESKIO is committed to enroll and follow 630 volunteers in the two networks. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI069421-06
Application #
8195400
Study Section
Special Emphasis Panel (ZAI1-AR-A (M1))
Program Officer
Castillo, Blanca E
Project Start
2007-02-01
Project End
2012-11-30
Budget Start
2011-12-01
Budget End
2012-11-30
Support Year
6
Fiscal Year
2012
Total Cost
$1,604,865
Indirect Cost
$80,342
Name
Gheskio Center
Department
Type
DUNS #
872038059
City
Port-Au-Prince
State
Country
Haiti
Zip Code
Touzard Romo, F; Smeaton, L M; Campbell, T B et al. (2014) Renal and metabolic toxicities following initiation of HIV-1 treatment regimen in a diverse, multinational setting: a focused safety analysis of ACTG PEARLS (A5175). HIV Clin Trials 15:246-60
Charles, Macarthur; Delva, Glavdia G; Boutin, Jethro et al. (2014) Importance of cholera and other etiologies of acute diarrhea in post-earthquake Port-au-Prince, Haiti. Am J Trop Med Hyg 90:511-7
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Pape, Jean W; Severe, Patrice D; Fitzgerald, Daniel W et al. (2014) The Haiti research-based model of international public health collaboration: the GHESKIO Centers. J Acquir Immune Defic Syndr 65 Suppl 1:S5-9
Haas, David W; Severe, Patrice; Jean Juste, Marc Antoine et al. (2014) Functional CYP2B6 variants and virologic response to an efavirenz-containing regimen in Port-au-Prince, Haiti. J Antimicrob Chemother 69:2187-90
McGreevy, J; Jean Juste, M A; Severe, P et al. (2012) Outcomes of HIV-infected patients treated for recurrent tuberculosis with the standard retreatment regimen. Int J Tuberc Lung Dis 16:841-5