The Northwestern University Clinical Trials Unit (NU-CTU) is an existing and very productive clinical unit within the AIDS Clinical Trails Group. The NU-CTU has been invited to participate in the current ACTG application for a Network which will focus on translational research/drug development, optimization of clinical management including co-morbidities, vaccine research and development, prevention of mother-to-child transmission and prevention of HIV infection. The NU-CTU consists of 5 individual clinical research sites (CRS) operating under the Northwestern University administrative umbrella. The 5 sites are: Northwestern University Clinical Research Site (NU-CRS), Rush University Clinical Research Site (R J-CRS), and the CORE Center Clinical Research Site (CC-CRS) all located in Chicago, an international site at Fann Hospital/Universite Cheikh Anta Diop in Dakar, Senegal (SN-CRS), and the Peabody Health Center, a member of the Black Clinical Research Consortium, located in Dallas (PC-CRS). The ACTG Leadership has invited the 3 existing ACTG sites, NU-CRS, RU-CRS, and CC-CRS to participate in this recompetitive network grant. The PC-CRS is not an existing site but it has received a special invitation to participate from the ACTG Leadership for the purpose of enhancing minority patient involvement and minority research investigator development. The SN-CRS was not formally invited as only existing ACTG international sites were eligible, however this site is an NIAID/CIPRA grant awardee and a Fogarty grantee and is fully capable of performing clinical trials to NIH standards. We include them now because they are as capable of performing clinical trials as the existing international sites, they would be the only site located in West Africa, the only site with patients predominantly infected with HIV-1 subtype A/G, and the only site with a significant minority of patients infected or co-infected with HIV-2.. We believe these unique features would greatly enhance the ACTG scientific agenda. The NU-CTU is a highly productive and efficient group with an already established track record in performing multicenter, translational research and therapeutic clinical trials, ranking #1 in patient accrual and #3 in scientific productivity for the last 5 year evaluation period. We expect a seamless transition to the new structure described in this application. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-SR-A (M2))
Program Officer
Tauscher, Gail H
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Northwestern University at Chicago
Internal Medicine/Medicine
Schools of Medicine
United States
Zip Code
La Rosa, Alberto M; Harrison, Linda J; Taiwo, Babafemi et al. (2016) Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV 3:e247-58
Koita, Ousmane A; Murphy, Robert L; Fongoro, Saharé et al. (2016) Clinical Research and the Training of Host Country Investigators: Essential Health Priorities for Disease-Endemic Regions. Am J Trop Med Hyg 94:253-7
Bedimo, Roger; Kang, Minhee; Tebas, Pablo et al. (2016) Effects of Pegylated Interferon/Ribavirin on Bone Turnover Markers in HIV/Hepatitis C Virus-Coinfected Patients. AIDS Res Hum Retroviruses 32:325-8
Weinberg, Adriana; Park, Jeong-Gun; Bosch, Ronald et al. (2016) Effect of Depot Medoxyprogesterone Acetate on Immune Functions and Inflammatory Markers of HIV-Infected Women. J Acquir Immune Defic Syndr 71:137-45
Riddler, Sharon A; Aga, Evgenia; Bosch, Ronald J et al. (2016) Continued Slow Decay of the Residual Plasma Viremia Level in HIV-1-Infected Adults Receiving Long-term Antiretroviral Therapy. J Infect Dis 213:556-60
Kelesidis, Theodoros; Moser, Carlee; Stein, James H et al. (2016) Changes in Markers of T-Cell Senescence and Exhaustion With Atazanavir-, Raltegravir-, and Darunavir-Based Initial Antiviral Therapy: ACTG 5260s. J Infect Dis 214:748-52
Maiga, Mamoudou; Cohen, Keira; Baya, Bocar et al. (2016) Stool microbiome reveals diverse bacterial ureases as confounders of oral urea breath testing for Helicobacter pylori and Mycobacterium tuberculosis in Bamako, Mali. J Breath Res 10:036012
Verma, Shefali S; Frase, Alex T; Verma, Anurag et al. (2016) PHENOME-WIDE INTERACTION STUDY (PheWIS) IN AIDS CLINICAL TRIALS GROUP DATA (ACTG). Pac Symp Biocomput 21:57-68
McComsey, Grace A; Moser, Carlee; Currier, Judith et al. (2016) Body Composition Changes After Initiation of Raltegravir or Protease Inhibitors: ACTG A5260s. Clin Infect Dis 62:853-62
Mathad, Jyoti S; Gupte, Nikhil; Balagopal, Ashwin et al. (2016) Sex-Related Differences in Inflammatory and Immune Activation Markers Before and After Combined Antiretroviral Therapy Initiation. J Acquir Immune Defic Syndr 73:123-9

Showing the most recent 10 out of 105 publications