Abstract

This is a clinical phase I/II trial to determine the safety and efficacy of anal-region ONYX-015 injections in HIV-infected individuals. All patients will have high-grade squamous intraepithelial neoplasia (HSIL) and HIV infection with a CD4 count of greater than 100. Multi-day (5) injections may be repeated monthly for up to 3 months. Local and systemic toxicity will be quantitated and reported. The response rate will be defined histologically. Correlative studies will be done on tissue to determine the association of p53 mutations, HPV integration, HPV subtype, immune status, and other factors on the outcome variables. The GCRC will be used for the outpatient treatments as has been the case for all prior phase I/II clinical trials of HIV anal dysplasia performed at UCSF. This will facilitate handling of the attenuated adenovirus and the specimens obtained from patients on study.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000079-37A1
Application #
6407581
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1974-12-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
37
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
University of California San Francisco
Department
Type
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143

  Publications

Kurtz, Theodore W; DiCarlo, Stephen E; Pravenec, Michal et al. (2018) Functional foods for augmenting nitric oxide activity and reducing the risk for salt-induced hypertension and cardiovascular disease in Japan. J Cardiol 72:42-49
Anderegg, Nanina; Johnson, Leigh F; Zaniewski, Elizabeth et al. (2017) All-cause mortality in HIV-positive adults starting combination antiretroviral therapy: correcting for loss to follow-up. AIDS 31 Suppl 1:S31-S40
Kurtz, Theodore W; DiCarlo, Stephen E; Morris Jr, R Curtis (2016) Logical Issues With the Pressure Natriuresis Theory of Chronic Hypertension. Am J Hypertens 29:1325-1331
Cruz, Giovanna I; Shao, Xiaorong; Quach, Hong et al. (2016) A Child's HLA-DRB1 genotype increases maternal risk of systemic lupus erythematosus. J Autoimmun 74:201-207
Morris Jr, R Curtis; Schmidlin, Olga; Sebastian, Anthony et al. (2016) Vasodysfunction That Involves Renal Vasodysfunction, Not Abnormally Increased Renal Retention of Sodium, Accounts for the Initiation of Salt-Induced Hypertension. Circulation 133:881-93
Kurtz, Theodore W; DiCarlo, Stephen E; Pravenec, Michal et al. (2016) An alternative hypothesis to the widely held view that renal excretion of sodium accounts for resistance to salt-induced hypertension. Kidney Int 90:965-973
Brambati, Simona Maria; Amici, Serena; Racine, Caroline A et al. (2015) Longitudinal gray matter contraction in three variants of primary progressive aphasia: A tenser-based morphometry study. Neuroimage Clin 8:345-55
Abraham, Alison G; Althoff, Keri N; Jing, Yuezhou et al. (2015) End-stage renal disease among HIV-infected adults in North America. Clin Infect Dis 60:941-9
Wang, Julie B; Pierce, John P; Ayala, Guadalupe X et al. (2015) Baseline Depressive Symptoms, Completion of Study Assessments, and Behavior Change in a Long-Term Dietary Intervention Among Breast Cancer Survivors. Ann Behav Med 49:819-27
Brehm, John M; Ramratnam, Sima K; Tse, Sze Man et al. (2015) Stress and Bronchodilator Response in Children with Asthma. Am J Respir Crit Care Med 192:47-56

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