title: Measurement of mucosal biomarkers in a phase 1 trial of intravaginal 3% StarPharma LTD 7013 gel (VivaGel) to assess expanded safety.
abstract: 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.
  
  
  METHODS
  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.
authors: Department of Pediatrics, University of California, San Francisco, CA 94118, USA. moscickia@peds.ucsf.edu
authors: Anna-Barbara
authors: AB
authors: Moscicki
authors: Rupert
authors: R
authors: Kaul
authors: Yifei
authors: Y
authors: Ma
authors: Mark E
authors: ME
authors: Scott
authors: Ibrahim I
authors: II
authors: Daud
authors: Elizabeth A
authors: EA
authors: Bukusi
authors: Stephen
authors: S
authors: Shiboski
authors: Anuradha
authors: A
authors: Rebbapragada
authors: Sanja
authors: S
authors: Huibner
authors: Craig R
authors: CR
authors: Cohen
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000494:pharmacology; D015415:Biomarkers / Q000378:metabolism; D002582:Cervix Mucus / Q000166:cytology / Q000276:immunology*; D018925:Chemokines / Q000378:metabolism; D016207:Cytokines / Q000378:metabolism; D050091:Dendrimers; D003713:Dendritic Cells / Q000166:cytology; D004311:Double-Blind Method; D005260:Female; D005782:Gels / Q000494:pharmacology; D006801:Humans; D007630:Kenya; D011107:Polylysine / Q000008:administration & dosage / Q000009:adverse effects*; D012044:Regression Analysis; D013601:T-Lymphocytes / Q000166:cytology; D014481:United States
chemical_list: D000890:Anti-Infective Agents; D015415:Biomarkers; D018925:Chemokines; D016207:Cytokines; D050091:Dendrimers; D005782:Gels; D011107:Polylysine; C480351:astodrimer