Dapivirine

Generic Name: Dapivirine

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₁₉N_₅

CAS Number: 244767-67-7

Unique Ingredient Identifier: TCN4MG2VXS

Background: Dapivirine has been investigated for the prevention of HIV-1 Infections and Topical Penile Exposures.

Clinical Trials

To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)

Phase 1

Completed

Conditions: HIV- Prevention

Interventions: Drug: Dapivirine Ring-004 for 28 days along with clotrimazole
Drug: Dapivirine Ring-004
Drug: Clotrimazole

First Posted Date: 2016-07-28

Last Posted Date: 2017-08-30

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 36

Registration Number: NCT02847286

Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women

Phase 1

Completed

Conditions: Human Immunodeficiency Virus

Interventions: Drug: Dapivirine

First Posted Date: 2016-06-22

Last Posted Date: 2018-03-13

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 16

Registration Number: NCT02808949

Locations: 🇺🇸
Alabama CRS, Birmingham, Alabama, United States

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

Phase 2

Completed

Conditions: Human Immunodeficiency Virus

Interventions: Drug: Dapivirine Vaginal Ring
Drug: Placebo Vaginal Ring

First Posted Date: 2013-12-13

Last Posted Date: 2022-11-03

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 96

Registration Number: NCT02010593

Locations: 🇺🇸
Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
Case CRS, Case Western Reserve University, 2061 Cornell Road, Room 303, Cleveland, Ohio, United States
🇺🇸
Alabama CRS, 84519th Street South, BBRB 203A, Birmingham, Alabama, United States

Expanded Use PK of Dapivirine Vaginal Ring

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: dapivirine ring

First Posted Date: 2013-09-30

Last Posted Date: 2016-08-26

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 40

Registration Number: NCT01952561

PK/PD of Single Dose Dapivirine Vaginal Film

Phase 1

Completed

Conditions: Pharmaokinetics

Interventions: Drug: Dapivirine gel
Drug: Dapivirine film

First Posted Date: 2013-08-16

Last Posted Date: 2017-09-08

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 60

Registration Number: NCT01924091

DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate

Phase 1

Completed

Conditions: HIV

Interventions: Drug: dapivirine
Drug: miconazole

First Posted Date: 2012-11-22

Last Posted Date: 2017-09-08

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 36

Registration Number: NCT01731574

Locations: 🇧🇪
SGS Life Sciences, Lange Beeldekensstraat 267, Antwerpen, Belgium

Assessing the Safety of Dapivirine Gel and Film Formulations

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Dapivirine Vaginal Film
Drug: Dapivirine Vaginal Gel

First Posted Date: 2012-03-08

Last Posted Date: 2017-09-08

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 60

Registration Number: NCT01548560

Locations: 🇺🇸
Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States

Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Dapivirine-Maraviroc Vaginal Ring
Other: Placebo Vaginal Ring
Drug: Maraviroc Vaginal Ring
Drug: Dapivirine Vaginal Ring

First Posted Date: 2011-06-01

Last Posted Date: 2015-09-10

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 48

Registration Number: NCT01363037

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
The Fenway Institute/Fenway Community Health, Boston, Massachusetts, United States
🇺🇸
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

Phase 3

Withdrawn

Conditions: HIV Infections

Interventions: Other: Placebo
Drug: Dapivirine

First Posted Date: 2011-04-19

Last Posted Date: 2012-06-11

Lead Sponsor: International Partnership for Microbicides, Inc.

Registration Number: NCT01337570

Locations: 🇿🇦
Qhakaza Mbokodo, Ladysmith, KwaZulu Natal, South Africa
🇿🇦
Madibeng Centre for Research (MCR), Brits, South Africa
🇲🇼
College of Medicine - Johns Hopkins Project (JHP), Blantyre, Malawi

and more 1 locations

A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa

Phase 3

Withdrawn

Conditions: HIV Infections

Interventions: Other: Placebo
Drug: Dapivirine

First Posted Date: 2011-04-19

Last Posted Date: 2012-06-11

Lead Sponsor: International Partnership for Microbicides, Inc.

Registration Number: NCT01337583

Locations: 🇰🇪
Suba District Hospital, Mbita, Kenya
🇿🇦
Desmond Tutu HIV Foundation, Nyanga (DTHF), Nyanga, Cape Town, South Africa
🇲🇼
University of North Carolina Project, Lilongwe, Malawi

and more 2 locations

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