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

Impact of Combined Oral Contraceptive Pills on Migraine

Phase 4

Recruiting

Conditions: Migraine

Interventions: Drug: Combined oral contraceptive
Drug: Vaginal Ring

First Posted Date: 2024-07-19

Last Posted Date: 2024-10-09

Lead Sponsor: Kafrelsheikh University

Target Recruit Count: 400

Registration Number: NCT06509503

Locations: 🇪🇬
Kafr Elsheikh University Hospital, Kafr Ash Shaykh, Egypt

Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: dapivirine

First Posted Date: 2022-06-13

Last Posted Date: 2024-07-03

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 124

Registration Number: NCT05416021

Locations: 🇿🇦
FARMOVS, Bloemfontein, South Africa

Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: Truvada Tablet
Drug: Dapivirine (DPV) Vaginal Ring (VR)-004

First Posted Date: 2019-10-25

Last Posted Date: 2023-08-04

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 394

Registration Number: NCT04140266

Locations: 🇺🇬
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda
🇲🇼
Blantyre CRS (Johns Hopkins Research Project/College of Medicine), Blantyre, Malawi
🇿🇼
Zengeza CRS, Chitungwiza, Mashonaland East, Zimbabwe

and more 1 locations

Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: Dapivirine (DPV) Vaginal Ring (VR)
Drug: Truvada Tablet

First Posted Date: 2019-05-29

Last Posted Date: 2025-01-22

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 1105

Registration Number: NCT03965923

Locations: 🇺🇬
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda
🇿🇦
Wits RHI Shandukani Research Centre CRS, Johannesburg, Gauteng, South Africa
🇲🇼
Blantyre CRS (Johns Hopkins Research Project/College of Medicine), Blantyre, Malawi

and more 1 locations

Pharmacokinetic Study of Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Dapivirine gel

First Posted Date: 2018-01-08

Last Posted Date: 2021-10-25

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 16

Registration Number: NCT03393468

Locations: 🇺🇸
University of Pittsburgh CRS, Pittsburgh, Pennsylvania, United States

Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Dapivirine gel
Drug: Placebo gel

First Posted Date: 2017-08-04

Last Posted Date: 2021-10-19

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 28

Registration Number: NCT03239483

Locations: 🇺🇸
University of Pittsburgh CRS, Pittsburgh, Pennsylvania, United States
🇹🇭
Silom Community Clinic CRS, Nonthaburi, Bangkok, Thailand
🇺🇸
Alabama CRS, Birmingham, Alabama, United States

Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)

Phase 2

Withdrawn

Conditions: HIV-1-infection

Interventions: Drug: Truvada
Drug: Dapivirine

First Posted Date: 2017-03-09

Last Posted Date: 2017-09-08

Lead Sponsor: International Partnership for Microbicides, Inc.

Registration Number: NCT03074786

Locations: 🇿🇦
CAPRISA, eThekwini Clinical Research Site, Durban, KwaZulu-Natal, South Africa

Dapivirine Gel Rectal Safety and PK Study

Phase 1

Withdrawn

Conditions: HIV 1 Infection

Interventions: Drug: Dapivirine gel (0.05%)
Other: Universal HEC placebo gel

First Posted Date: 2017-02-07

Last Posted Date: 2017-02-08

Lead Sponsor: International Partnership for Microbicides, Inc.

Registration Number: NCT03044379

Locations: 🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women

Phase 3

Completed

Conditions: HIV Prevention

Interventions: Drug: Dapivirine Vaginal Ring-004

First Posted Date: 2016-08-10

Last Posted Date: 2022-10-25

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 941

Registration Number: NCT02862171

Locations: 🇿🇦
Madibeng Centre for Research, Brits, North West, South Africa
🇿🇦
Ndlovu Medical Centre, Elandsdoorn, South Africa
🇺🇬
MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda

and more 3 locations

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

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Dapivirine Vaginal Ring-004 and no tampons
Drug: Dapivirine Vaginal Ring-004 with tampons
Drug: Dapivirine Vaginal Ring-004 and same ring inserted after menses
Drug: Dapivirine Vaginal Ring-004 with no menses
Drug: Dapivirine Vaginal Ring-004 and new ring inserted after menses

First Posted Date: 2016-08-08

Last Posted Date: 2017-09-06

Lead Sponsor: International Partnership for Microbicides, Inc.

Target Recruit Count: 16

Registration Number: NCT02858024

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