Our focus as an HIV research clinic continues to address several important aspects of the following questions: how to optimally use and administer multi-class combination anti-retroviral therapy;how to integrate immune based therapies within a framework of ongoing antiretroviral therapy;how to determine the optimal time for initiation of antiretroviral strategy in order to preserve and reconstitute immune function while at the same time minimizing long-term antiretroviral toxicities, and what are some of the predictive factors for the development of adverse consequences of progressive HIV infection both on and off antiretroviral medications. In the Clinical Research Section (CRS) of the Laboratory of Immunoregulation we remain dedicated to the successful enrollment and completion of the """"""""START"""""""" study (Strategic Timing of AntiRetroviral Treatment) aimed at determining whether early introduction of ART in previously-untreated patients translates into better clinical outcomes. Current Department of Health and Human Services Antiretroviral Guidelines recommend the initiation of HAART for HIV-infected individuals with CD4 cell counts of 500 cells/L or less, but also strongly recommend consideration of initiating antiretroviral treatment even in those with higher CD4 cell counts. However, these recommendations are controversial in that they are based upon the outcomes of large observational trials and expert opinion rather than on data from a randomized clinical trial. In order to address this question more rigorously and definitely, the START trial is a large multi-national trial enrolling antiretroviral-naive HIV-infected individuals with CD4 cell counts above 500 cells/L and randomly assigning them either to begin HAART immediately or to delay the start of HAART until the CD4 cell count falls below 350 cells/L. The primary goal of this 4-5 year trial is to compare the two arms in terms of the cumulative incidence of adverse consequences (both AIDS-related and non-AIDS related) ascribable either to progressive HIV infection or to the toxicities of HAART itself. With this and with our other HIV trials we also continue our efforts to improve access to clinical trials by local minority populations through an outreach that includes a close relationship with local clinics for medically under-served populations.

Project Start
Project End
Budget Start
Budget End
Support Year
14
Fiscal Year
2013
Total Cost
$502,342
Indirect Cost
City
State
Country
Zip Code
INSIGHT Strategic Timing of AntiRetroviral Treatment (START) Study Group; Lundgren, Jens; Babiker, Abdel et al. (2015) Why START? Reflections that led to the conduct of this large long-term strategic HIV trial. HIV Med 16 Suppl 1:1-9
Cortez, K J; Proschan, M A; Barrett, L et al. (2013) Baseline CD4+ T-cell counts predict HBV viral kinetics to adefovir treatment in lamivudine-resistant HBV-infected patients with or without HIV infection. HIV Clin Trials 14:149-59
Maldarelli, Frank; Kearney, Mary; Palmer, Sarah et al. (2013) HIV Populations Are Large and Accumulate High Genetic Diversity in a Nonlinear Fashion. J Virol 87:10313-23
Sherman, Amy C; Trehanpati, Nirupama; Daucher, Marybeth et al. (2013) Augmentation of hepatitis B virus-specific cellular immunity with programmed death receptor-1/programmed death receptor-L1 blockade in hepatitis B virus and HIV/hepatitis B virus coinfected patients treated with adefovir. AIDS Res Hum Retroviruses 29:665-72
Catalfamo, Marta; Wilhelm, Christopher; Tcheung, Lueng et al. (2011) CD4 and CD8 T cell immune activation during chronic HIV infection: roles of homeostasis, HIV, type I IFN, and IL-7. J Immunol 186:2106-16
Belloso, Waldo H; Romano, Marina; Greco, Graciela S et al. (2011) Recurrent Meningitis and Subarachnoid Hemorrhage Due to Salmonella in an HIV+ Patient: Case Report and Mini-Review of the Literature. Open AIDS J 5:62-6
Holmes, Edward C; Ghedin, Elodie; Halpin, Rebecca A et al. (2011) Extensive geographical mixing of 2009 human H1N1 influenza A virus in a single university community. J Virol 85:6923-9
Reynolds, Steven J; Kityo, Cissy; Hallahan, Claire W et al. (2010) A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda. PLoS One 5:e10307
Tavel, Jorge A; Huang, Chiung-Yu; Shen, Jean et al. (2010) Interferon-alpha produces significant decreases in HIV load. J Interferon Cytokine Res 30:461-4
Moss, Ronald B; Davey, Richard T; Steigbigel, Roy T et al. (2010) Targeting pandemic influenza: a primer on influenza antivirals and drug resistance. J Antimicrob Chemother 65:1086-93

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