Primary HIV infection provides a unique opportunity to study pathogenesis of early disease, to measure the effects of therapy when initiated at the earliest stages of infection, and to determine the epidemiology of newly-infected patients including the prevalence of drug resistant virus. We have established a collaborative program between the University of California San Diego (UCSD) and the University of Texas Southwestern Medical Center to combine the resources and expertise in patient recruitment, clinical trials and pathogenetic research. The collaborative project has 3 aims.
Aim 1 : Primary Infection Cohort. We shall identify, recruit and retain 100 subjects with acute or early HIV (AEHIV) infection from San Diego and Dallas Counties. Programs to facilitate participation of women, minorities and injection drug users will be implemented through established and novel programs.
Aim 2 : Clinical Trials. Two innovative trials have been designed-one to test the hypothesis that patients randomized to receive directly observed antiretroviral therapy in our maximally assisted therapy program (MAT) will have greater adherence and hence more potent antiviral effect than individuals self administering therapy; the other a pilot trial of the immunoregulatory cytokine IL-10. Pilot studies to address factors influencing retention, adherence, quality of life will be included with special expertise in health care outcomes.
Aim 3 : Pathogenesis. A series of important questions on dynamics of acute HIV infection, immune reconstitution, and tissue and cellular reservoirs are proposed. These will be addressed with the extensive and complementary expertise at the two institutions in virology and immunology. In addition we have established collaborative arrangements with several outstanding investigators who add expertise that will significantly enhance this proposal. Of note, 35 AEHIV patients were identified last year in San Diego and many components of this project are established and functioning, not merely proposed. Specimen collection with banking and distribution is in place, clinical trials and data management are well-established and both published and pilot laboratory investigations have been conducted.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project--Cooperative Agreements (U01)
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Study Section
Special Emphasis Panel (ZAI1-ACS-A (M1))
Program Officer
Batzold, Frederick
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University of California San Diego
Internal Medicine/Medicine
Schools of Medicine
La Jolla
United States
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Chaillon, Antoine; Gianella, Sara; Lada, Steven M et al. (2018) Size, Composition, and Evolution of HIV DNA Populations during Early Antiretroviral Therapy and Intensification with Maraviroc. J Virol 92:
Beliakova-Bethell, Nadejda; Hezareh, Marjan; Wong, Joseph K et al. (2017) Relative efficacy of T cell stimuli as inducers of productive HIV-1 replication in latently infected CD4 lymphocytes from patients on suppressive cART. Virology 508:127-133
Morris, Sheldon R; Zhao, Mitchell; Smith, Davey M et al. (2017) Longitudinal Viral Dynamics in Semen During Early HIV Infection. Clin Infect Dis 64:428-434
Osorio, Georgina; Hoenigl, Martin; Quartarolo, Jennifer et al. (2017) Evaluation of opt-out inpatient HIV screening at an urban teaching hospital. AIDS Care 29:1014-1018
Moore, Camille M; MaWhinney, Samantha; Forster, Jeri E et al. (2017) Accounting for dropout reason in longitudinal studies with nonignorable dropout. Stat Methods Med Res 26:1854-1866
Macatangay, Bernard J; Yang, Ming; Sun, Xin et al. (2017) Brief Report: Changes in Levels of Inflammation After Antiretroviral Treatment During Early HIV Infection in AIDS Clinical Trials Group Study A5217. J Acquir Immune Defic Syndr 75:137-141
Pines, Heather A; Karris, Maile Y; Little, Susan J (2017) Sexual Partner Concurrency Among Partners Reported by MSM with Recent HIV Infection. AIDS Behav 21:3026-3034
Gianella, Sara; Chaillon, Antoine; Mutlu, Ece A et al. (2017) Effect of cytomegalovirus and Epstein-Barr virus replication on intestinal mucosal gene expression and microbiome composition of HIV-infected and uninfected individuals. AIDS 31:2059-2067
Hoenigl, Martin; Braun, Dominique L; Kouyos, Roger et al. (2017) Evaluation of the Predictive Potential of the Short Acute Retroviral Syndrome Severity Score for HIV-1 Disease Progression in Individuals With Acute HIV Infection. J Acquir Immune Defic Syndr 74:e114-e117
Graves, Susannah K; Little, Susan J; Hoenigl, Martin (2017) Risk profile and HIV testing outcomes of women undergoing community-based testing in San Diego 2008-2014. Sci Rep 7:42183

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