Clinical Trial

Tenofovir Rectal Douche to Prevent HIV Transmission

Study Description

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Tenofovir douche

660 mg TFV in 125 mL hypo-osmolar solution

Additional Information

Official Study Title

A Phase I, Open-label Multiple Dose Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Tenofovir Rectal Douche

Clinical Trial ID

NCT04016233

ParticipAid ID

erkGpa