Abstract

The goal of this application is to prepare the GHESKIO Centers in Port-au-Prince, Haiti for a multi-project CIPRA in five years. This goal will be achieved through the conduct of a randomized clinical trial of early versus delayed antiretroviral therapy for people with pre-AIDS symptomatic HIV disease and through research training and capacity building. The GHESKIO Centers, directed by Jean Pape, is a Haitian non-governmental research and training organization working in close partnership with the Haitian Government on HIV/AIDS. Over the next five years, GHESKIO will become a regional HIV/AIDS center providing training and conducting research in collaboration with partners in Haiti and the Caribbean.
The specific aims are:
Aim 1 : To determine the optimal time to start antiretroviral therapy (ART). We propose to conduct a randomized clinical trial to determine the outcome of early versus delayed antiretroviral therapy (ART) in HIV infected adults with pre-AIDS symptomatic HIV disease (WHO Sate II or III symptoms, such as pulmonary TB, chronic diarrhea, or oral thrush) and a CD4 count between 200 and 350 cells/mm3. The primary hypothesis is: Early initiation of ART in HIV infected adults with pre-AIDS symptoms and a CD4 count between 200 and 350 cells/mm3 will improve survival at 36 months when compared to delaying ART until subjects develop clinical AIDS (WHO stage IV) or CD4 count <200 cells/mm3.
Aim 2 : To build on the existing capacity of the GHESKIO Center in Port au Prince Haiti and to prepare for a multi-project CIPRA within five years. Capacity will be increased in: 1) Administration, including development of an advisory council, increasing ethics capacity, strengthening grants management, and strengthening training. 2) Clinical investigation; 3) Data management and analysis; 4) Laboratory capacity including HIV virology and immunology. In each of these capacity building areas, we have identified promising young Haitians who will participate in the CIPRA project and who will also receive advanced training and mentorship by senior investigators from the US. These Haitians will be leaders in a multi-project CIPRA in five years.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AI058257-05S1
Application #
7895126
Study Section
Special Emphasis Panel (ZAI1-GLM-A (S1))
Program Officer
Roth, Lynnea L
Project Start
2004-02-01
Project End
2011-05-31
Budget Start
2009-07-22
Budget End
2011-05-31
Support Year
5
Fiscal Year
2009
Total Cost
$385,224
Indirect Cost

  Institution

Name
Gheskio Center
Department
Type
DUNS #
872038059
City
Port-Au-Prince
State
Country
Haiti
Zip Code

  Publications

Batavia, Ashita S; Secours, Rode; Espinosa, Patrice et al. (2016) Diagnosis of HIV-Associated Oral Lesions in Relation to Early versus Delayed Antiretroviral Therapy: Results from the CIPRA HT001 Trial. PLoS One 11:e0150656
Collins, S E; Jean Juste, M A; Koenig, S P et al. (2015) CD4 deficit and tuberculosis risk persist with delayed antiretroviral therapy: 5-year data from CIPRA HT-001. Int J Tuberc Lung Dis 19:50-7
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
Koenig, Serena P; Bang, Heejung; Severe, Patrice et al. (2011) Cost-effectiveness of early versus standard antiretroviral therapy in HIV-infected adults in Haiti. PLoS Med 8:e1001095
Severe, Patrice; Juste, Marc Antoine Jean; Ambroise, Alex et al. (2010) Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. N Engl J Med 363:257-65
Dillingham, Rebecca A; Pinkerton, Relana; Leger, Paul et al. (2009) High early mortality in patients with chronic acquired immunodeficiency syndrome diarrhea initiating antiretroviral therapy in Haiti: a case-control study. Am J Trop Med Hyg 80:1060-4
Leger, Paul; Charles, Macarthur; Severe, Patrice et al. (2009) 5-year survival of patients with AIDS receiving antiretroviral therapy in Haiti. N Engl J Med 361:828-9
Charles, Macarthur; Noel, Francine; Leger, Paul et al. (2008) Survival, plasma HIV-1 RNA concentrations and drug resistance in HIV-1-infected Haitian adolescents and young adults on antiretrovirals. Bull World Health Organ 86:970-7

Showing the most recent 10 out of 13 publications