Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 19, 2013

Primary Completion Date

November 6, 2014

Study Completion Date

November 6, 2014

Conditions
HIV
Interventions
DRUG

TDF Intravaginal Ring

The TDF IVR intravaginal ring is formulated using flexible outer tubing, comprised of hydrophilic, aliphatic polyether urethane, and an inner core compartment comprised of 86% w/w TDF and 14% w/w sodium chloride (NaCl). The TDF intravaginal ring will be worn continuously for 14 days. It will be inserted into the vagina following cessation of participant's menses at Visit 3 and removed at Visit 7.

DRUG

Placebo Intravaginal Ring

The placebo ring is formulated using flexible outer tubing, comprised of hydrophilic, aliphatic polyether urethane, and an inner core comprised of sodium chloride (NaCl). The Placebo intravaginal ring will be worn continuously for 14 days. It will be inserted into the vagina following cessation of participant's menses at Visit 3 and removed at Visit 7.

Trial Locations (1)

10461

Albert Einstein College of Medicine, The Bronx

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Albert Einstein College of Medicine

OTHER

NCT02006264 - Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring | Biotech Hunter | Biotech Hunter