NCT02858024 - A Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 12, 2015

Primary Completion Date

April 16, 2016

Study Completion Date

April 16, 2016

Conditions

HIV

Interventions

DRUG

Dapivirine Vaginal Ring-004 and no tampons

Dapivirine Vaginal Ring-004 for 28 days, with menses, no tampon use (Treatment A),

DRUG

Dapivirine Vaginal Ring-004 with tampons

followed by Dapivirine Vaginal Ring-004 for 28 days, with menses, with tampon use (Treatment B)

DRUG

Dapivirine Vaginal Ring-004 with no menses

Dapivirine Vaginal Ring-004 for 28 days, with no menses occurring (Treatment E; treatment period 3).

DRUG

Dapivirine Vaginal Ring-004 and same ring inserted after menses

Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and the same ring re-inserted five days later (estimated completion of menses) (Treatment C)

DRUG

Dapivirine Vaginal Ring-004 and new ring inserted after menses

Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and a new ring inserted five days later (estimated completion of menses) (Treatment D)

All Listed Sponsors

lead

International Partnership for Microbicides, Inc.

INDUSTRY