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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Measurement of mucosal biomarkers in a phase 1 trial of intravaginal 3% starpharma LTD 7013 gel (vivagel) to assess expanded safety
Journal of Acquired Immune Deficiency Syndromes, Volume 59, No. 2, Year 2012
Notification
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Description
Objective: The aim of this study was to examine the effect of the 3% StarPharma LTD 7013 gel (VivaGel) on mucosal immune markers hypothesized to be associated with HIV-1 acquisition. Design: Phase 1, placebo-controlled, randomized, double-blind clinical trial was performed in 54 young women in the United States and Kenya. Participants used carbopol gel with and without (placebo) StarPharma LTD 7013 twice daily over 14 days. Cervical specimens were collected for cytokines, chemokines, T cells, and dendritic cells at days 0, 7, 14, and 21. A negative binomial regression model was used to assess differences between study arms. Results: Several mucosal immune parameters were increased in the VivaGel arm compared with placebo. For cytokines D7, IL-6 (P = 0.05); D 14, interferon gamma (P = 0.03), IL-2 (P = 0.04), IL-5 (P = 0.003), and IL-10 (P = 0.001) were increased. On D7, CD8+/CD69+ T cells tended to be increased (P < 0.08); limiting analysis to visits without blood or bacterial vaginosis, these findings were stronger as follows: at D7, CD8+/CD69+ T cells were increased in the VivaGel arm (P , 0.005), as were CD4+/CD69+ cells (P = 0.001) and CD4+/CCR5+ T cells (P = 0.01). The changes described for D7 and 14 were no longer seen at D21. Conclusions: Markers associated with inflammation and epithelial damage were reversibly elevated in the VivaGel arm compared with the placebo arm after 7-14 days of twice daily product use. Copyright © 2012 Lippincott Williams & Wilkins.
Authors & Co-Authors
Mościcki, Anna Barbara
United States, San Francisco
University of California, San Francisco
Kaul, Rupert
Canada, Toronto
University of Toronto
Yifei, M. A.
United States, San Francisco
University of California, San Francisco
Scott, Mark E.
United States, San Francisco
University of California, San Francisco
Daud, Ibrahim I.
Kenya, Nairobi
Kenya Medical Research Institute
Bukusi, Elizabeth Anne
Kenya, Nairobi
Kenya Medical Research Institute
Shiboski, Stephen C.
United States, San Francisco
University of California, San Francisco
Rebbapragada, Anuradha
Canada, Toronto
University of Toronto
Huibner, Sanja
Canada, Toronto
University of Toronto
Cohen, Craig R.
United States, San Francisco
University of California, San Francisco
Statistics
Citations: 55
Authors: 10
Affiliations: 3
Identifiers
Doi:
10.1097/QAI.0b013e31823f2aeb
ISSN:
15254135
Research Areas
Disability
Infectious Diseases
Study Locations
Kenya
Participants Gender
Female