Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women

PHASE2CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Human Immunodeficiency Virus
Interventions
DRUG

Dapivirine Vaginal Ring

Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted amino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-\[\[4-\[(2,4,6-trimethylphenyl)amino\]-2- pyrimidinyl\]amino\]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR

DRUG

Placebo Vaginal Ring

The placebo VR is a flexible, platinum-catalyzed-cured silicone matrix ring, identical to dapivirine Ring-004, containing no active drug.

Trial Locations (3)

15213

Magee Women's Hospital of UPMC, Pittsburgh

44106

Case CRS, Case Western Reserve University, 2061 Cornell Road, Room 303, Cleveland

35294-2170

Alabama CRS, 84519th Street South, BBRB 203A, Birmingham

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

International Partnership for Microbicides, Inc.

INDUSTRY

NCT02010593 - Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women | Biotech Hunter | Biotech Hunter