Tanzania
Research Article
Pharmacokinetics and Safety Assessment of Anti-HIV Dapivirine Vaginal Microbicide Rings with Multiple Dosing
Author(s): Annalene M Nel, Wouter Haazen, Jeremy P Nuttall, Joseph W Romano, Pedro MM Mesquita, Betsy C Herold, Zeda F Rosenberg and Neliette van NiekerkAnnalene M Nel, Wouter Haazen, Jeremy P Nuttall, Joseph W Romano, Pedro MM Mesquita, Betsy C Herold, Zeda F Rosenberg and Neliette van Niekerk
Objectives: Self-administered vaginal rings are a promising method for delivery of topical anti-HIV microbicides and might offer an adherence advantage over daily or coitally-dependent dosage forms such as gels. This trial assessed the safety and pharmacokinetic aspects of the Dapivirine Vaginal Ring-004 when worn as multiple rings over sequential periods of ring use by healthy, sexually-active, HIV-negative women. Methods: This double-blind trial was conducted among 48 women (18-40 years). Participants were randomly assigned to two groups (A or B) and received (3:1) either the dapivirine or a placebo vaginal ring. Group A used two rings over a 56-day period and Group B used three rings over a 57-day period. Safety evaluations were conducted throughout the trial. Dapivirine concentrations were measured in plasma, vaginal fluid and cervical tissue samples collected during and after the.. Read More»
DOI:
10.4172/2155-6113.1000355
Journal of AIDS & Clinical Research received 5061 citations as per Google Scholar report