Weill Medical College of Cornell University

Through clinical and operational research, GHESKIO seeks to define treatment and prevention models for HIV/AIDS and related diseases that are appropriate and effective for Haiti. The main focus of the research is HIV, sexually transmitted infections, and tuberculosis. The GHESKIO research program has evolved from early observational studies to large clinical trials and its designation as an NIH clinical trials unit. In 1983, GHESKIO received its initial funding from the National Institutes of Health to define the epidemiology, natural history, risk factors, and associated co-infections of HIV/AIDS. Since then, GHESKIO�s consistent research productivity has been recognized by uninterrupted support from the National Institutes of Health, a MERIT award in 1990, and 25 new or competitive renewal grants. GHESKIO also conducts research with support from the World Health Organization and the French Government�s National Agency for AIDS Research.

HIV/AIDS: Charles, Fitzgerald, Gulick, Johnson, Pape. Ongoing research projects include a randomized controlled clinical trial of early vs. late antiretroviral therapy for AIDS patients (NIHsponsored CIPRA study; 2003 � 2010). The research is focused on finding the optimal time to start antiretroviral therapy in patients with CD4 counts between 200 and 350 cells/ml. GHESKIO is a member of an international collaboration of scientists and educators searching for an effective and safe HIV vaccine (NIH-sponsored HIV Vaccine Trials Network; 2001 � 2013). GHESKIO Director Dr. Jean Pape is the Principal Investigator of the HIV Vaccine Trials Network in Haiti and GHESKIO investigators conduct clinical trials of promising new HIV vaccine candidates. GHESKIO also is a member of an international group of scientists dedicated to developing treatment strategies for HIV and related disorders (NIH-sponsored AIDS Clinical Trials Group; 2002 � 2013). GHESKIO conducts clinical trials to evaluate the efficacy of antiretroviral treatment for HIV infected individuals in resource-limited countries. Research continues to evaluate the efficacy and feasibility of other AIDS prevention and treatment programs. GHESKIO investigators are evaluating the cost-effectiveness of HIV prevention and care services to maximize efficiency and demonstrate the feasibility of treatment programs in developing countries.

• Charles M, Noel F, Leger P, Severe P, Riviere C, Beauharnais CA, Miller E, Rutledge J, Bang H, Shealey W, D'Aquila RT, Gulick RM, Johnson WD Jr, Wright PF, Pape JW, Fitzgerald DW. Survival, plasma HIV-1 RNA concentrations and drug resistance in HIV- 1-infected Haitian adolescents and young adults on antiretrovirals. Bull World Health Organ 2008;86:970-77.
• George E, Beauharnais CA, Brignoli E, Noel F, Bois G, De Matteis Rouzier P, Altenor M, Lauture D, Hosty M, Mehta S, Wright PF, Pape JW. Potential of a simplified p24 assay for early diagnosis of infant human immunodeficiency virus type 1 infection in Haiti. J Clin Microbiol 2007;45:3416-18.
• Leger P, Charles M, Severe P, Riviere C, Pape JW, Fitzgerald DW. 5-year survival of patients with AIDS receiving antiretroviral therapy in Haiti. N Engl J Med 2009;361:828- 29.
• Severe P, Jean Juste MA, Ambroise A, Eliacin L, Marchand C, Apollon S, Edwards A, Bang H, Nicotera J, Godfrey C, Gulick RM, Johnson WD, Pape JW, Fitzgerald DW. Early versus standard antiretroviral therapy for HIV infected adults in Haiti. N Engl J Med 2010;363:257-65.
• Severe P, Leger P, Charles M, Noel F, Bonhomme G, Bois G, George E, Kenel-Pierre S, Wright P, Gulick R, Johnson WD, Pape JW, Fitzgerald DW. Antiretroviral therapy in a thousand patients with AIDS in Haiti. N Engl J Med 2005;353:2325-34.

TUBERCULOSIS: Fitzgerald, Johnson, Pape, Ocheretina. GHESKIO currently treats over 1,000 patients with active tuberculosis as well as patients with multi-drug resistant tuberculosis. Research includes studies of the interactions between HIV and tuberculosis and optimal treatment for co-infected patients, new diagnostic tests for tuberculosis, and the epidemiology of multi-drug resistant tuberculosis in Haiti.

• Joseph P, Severe P, Ferdinand S, Goh KS, Sola C, Haas DW, Johnson WD, Rastogi N, Pape JW, Fitzgerald DW. Multidrug-resistant tuberculosis at an HIV testing center in Haiti. AIDS 2006;20:415-18.
• Koenig SP, Riviere C, Leger P, Joseph P, Severe P, Parker K, Collins S, Lee E, Pape JW, Fitzgerald DW. High mortality among patients with AIDS who received a diagnosis of tuberculosis in the first 3 months of antiretroviral therapy. Clin Infect Dis 2009;48:829- 31.

SEXUALLY TRANSMITTED DISEASES: Fitzgerald, Johnson, Pape. Studies of sexually transmitted diseases include the evaluation of rapid syphilis diagnostics for the elimination of congenital syphilis in Haiti (2002 � 2011); the goal of this project is to improve syphilis screening throughout the country to reduce deaths due to congenital syphilis. Support is from the United Nations Development Program, the World Bank, and the World Health Organization�s Special Program for Research and Training in Tropical Disease. STD studies also include NIH sponsored research on the natural history of HIV and HPV co-infection and AIDS related cervical cancer.

• Herring AJ, Ballard RC, Pope V, Adegbola RA, Changalucha J, Fitzgerald DW, Hook EW 3rd, Kubanova A, Mananwatte S, Pape JW, Sturm AW, West B, Yin YP, Peeling RW. A multi-centre evaluation of nine rapid, point-of-care syphilis tests using archived sera. Sex Transm Infect 2006;82 Suppl 5:v7-12.
• Schackman BR, Neukermans CP, Fontain SN, Nolte C, Joseph P, Pape JW, Fitzgerald DW. Cost-effectiveness of rapid syphilis screening in prenatal HIV testing programs in Haiti. PLoS Med 2007;4:e183.