Partnering with Venn’s Pharmacokinetics team
Why partner with Venn’s Pharmacokinetics Team?
Venn Life Sciences contributes to International Partnership for Microbicides (IPM) clinical pharmacology program by providing a diverse range of services (e.g. consultancy, non-compartmental pharmacokinetic (PK) analysis, population-PK modelling, medical writing services). The full IPM program focused on the analysis of clinical trial data performed in thousands of women participants across numerous African and Western countries to develop a discreet and easy to use dapivirine vaginal ring for HIV-1 risk reduction in women at risk of infection. Two large phase 3 clinical studies have shown to reduce women’s risk of HIV-1 infection. This important work by IPM is needed because HIV/AIDS remains the leading cause of death among women ages 15-44 worldwide.
In support of the phase 3 program, a drug-drug interaction study has recently been performed and completed, investigating the co-administration of Dapvirine Vaginal Ring with clotrimazole vaginal cream. Venn contributed to this study with PK consultancy, PK analysis and medical writing support. The study concluded that local and systemic dapivirine exposure was similar in the presence and absence of vaginal clotrimazole. A modest increase in systemic clotrimazole exposure (33%) in the presence of dapivirine was observed but was not considered clinically relevant. Dapivirine Vaginal Ring was well tolerated, and safety findings were similar to the safety findings observed in earlier trials.