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.
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