“Tenofovir Rectal Douche to Prevent HIV Transmission”
DREAM-03 is an early phase-1, open label study to compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 sequences of tenofovir (TFV) and non-medicated douches. The overall goal is to inform the design of an extended safety study of an on-demand and behaviorally congruent TFV douche to confer protection from HIV acquisition in an outpatient pre-RAI context.
Drug - Tenofovir douche
660 mg TFV in 125 mL hypo-osmolar solution
A Phase I, Open-label Multiple Dose Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Tenofovir Rectal Douche