Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women

Status:Completed
Phase:Open Label
Principal Investigator(s):Kathleen L Vincent, MD
Objective:This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC ("Triple" IVR).   Last updated May 15, 2021
Prevention Option(s):Microbicides
Study Design:Open label
Arms and Assigned Interventions
DescriptionAll subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
Mode of DeliveryRing
ARMsExperimental
DescriptionIf the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
Mode of DeliveryRing
ARMsExperimental
DescriptionIf the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
Mode of DeliveryRing
ARMsExperimental
Results: eCollection 2018 Sep. Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial
Official Code: NCT02431273
Related Publications:
Combination Pod-Intravaginal Ring Delivers Antiretroviral Agents for HIV Prophylaxis: Pharmacokinetic Evaluation in an Ovine Model
Trial Sponsors: Auritec Pharmaceuticals (ARV-IVR 01)
Start Date
End Date
June 5, 2015
December 17, 2016
Enrollment:6
Age range: 18 Years ↔ 45 Years
Population: