Drugs / dapivirine

Trials 37

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 120 trials
Phase 1 NCT05041699 Jun 2022 → Oct 2024 hemorrhagic disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT03467347 Jul 2018 → Aug 2019 — International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT03393468 May → Dec 2018 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT03234400 Dec 2017 → Oct 2018 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT03239483 Oct 2017 → Sep 2018 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT02855346 May → Aug 2017 — International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT02808949 Feb 2015 → Mar 2018 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT01952561 Nov 2013 → Mar 2014 — International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT01924091 Sep 2013 → Sep 2014 — International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT01731574 Dec 2012 → Oct 2013 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT00917891 Nov 2009 → Jan 2011 AIDS International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1/2 NCT00917904 Jul 2009 → Sep 2010 AIDS International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1/2 NCT00309205 Dec 2005 → ? HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1/2 NCT00303576 Oct 2005 → Jul 2006 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1/2 NCT00304668 — HIV infectious disease International Partnership for Microbicides, Inc. Withdrawn No outcome recorded
Phase 23 trials
Phase 2 NCT03074786 Nov 2017 → Dec 2018 HIV infectious disease International Partnership for Microbicides, Inc. Withdrawn No outcome recorded
Phase 2 NCT02028338 Jun 2014 → Jul 2016 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 2 NCT02010593 Dec 2013 → Apr 2015 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 38 trials · 1 met primary
Phase 3 NCT06250504 Feb 2024 → Apr 2026 overdue HIV infectious disease Africa Health Research Institute Recruiting No outcome recorded
Phase 3 NCT04140266 Sep 2020 → Nov 2021 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT03965923 Jan 2020 → May 2024 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT02858037 Jul 2016 → Oct 2018 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 3 NCT02862171 Jul 2016 → Jan 2019 — International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 3 NCT01617096 Jul 2012 → Jul 2015 HIV infectious disease International Partnership for Microbicides, Inc. Completed Met primary
Phase 3 NCT01337583 Jul 2011 → Jul 2014 HIV infectious disease International Partnership for Microbicides, Inc. Withdrawn No outcome recorded
Phase 3 NCT01337570 Jul 2011 → Jul 2014 HIV infectious disease International Partnership for Microbicides, Inc. Withdrawn No outcome recorded
Phase not applicable1 trial · 1 met primary
— NCT01539226 Mar 2012 → Dec 2016 HIV infectious disease International Partnership for Microbicides, Inc. Completed Met primary
Comparator or background therapy7 trials
Phase 1 NCT05416021 Comparator Aug 2022 → Apr 2024 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT03044379 Comparator Sep 2015 → Sep 2017 HIV infectious disease International Partnership for Microbicides, Inc. Withdrawn No outcome recorded
Phase 1 NCT02847286 Comparator Sep 2015 → Nov 2016 — International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT02858024 Comparator Jan 2015 → Apr 2016 HIV infectious disease International Partnership for Microbicides, Inc. Completed No outcome recorded
Phase 1 NCT01277640 Comparator Mar → Jul 2011 — International Partnership for Microbicides, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-06-26 Popcouncil Regulatory Dapivirine Vaginal Ring Recommended as an HIV Prevention Option for Adolescent Girls popcouncil.org ↗
The Population Council is pleased to announce that the monthly dapivirine vaginal ring (DVR) for HIV prevention is now recommended for adolescent girls ages 16 years and older.
2024-10-07 Popcouncil Results 3-Month Dapivirine Vaginal Ring for HIV Prevention Demonstrates Superior Drug Release Compared to 1-Month Ring popcouncil.org ↗
The trial found that a 3-month dapivirine vaginal ring delivers the active antiretroviral drug, dapivirine, at higher levels than the 1-month dapivirine vaginal ring.
2022-03-11 Janssen Research & Development, LLC Regulatory South Africa Health Products Regulatory Authority Approves Dapivirine Ring Developed by the International Partnership for Microbicides jnj.com ↗
The approval of the dapivirine ring in South Africa is an important step in the decades-long fight against HIV, which is one of the most significant challenges in global health.

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 49 sources stand behind the page.

FieldValueCited text
Known as dapivirine “We evaluated the acceptability of the 90-day dapivirine levonorgestrel ring (DPV-LNG ring) used for 14 days compared to a dapivirine-only ring (DVR-200mg) in MTN-030/IPM 041 (n...” PMID 39808648 ↗ Jan 2025
43

“containing the active ingredients dapivirine (DPV) and levonorgestrel (LNG), formulated as IPM VR: 200 mg DPV + 320 mg LNG (Ring-102)” NCT03467347 ↗

“To start, the dapivirine vaginal ring will be included among the other forms of PrEP that are available.” NCT07076043 ↗

“They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine).” NCT00700284 ↗

“DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel” NCT05041699 ↗

NCT03965923 ↗

NCT02028338 ↗

NCT01617096 ↗

NCT03393468 ↗

NCT00613249 ↗

NCT02858037 ↗

Show 33 more sources

Known as [14C]DAPIVIRINE ChEMBL registry synonym — accepted as the source's own label CHEMBL70663 ↗
Known as AIDS-105293 ChEMBL registry synonym — accepted as the source's own label CHEMBL70663 ↗
Known as DAPIRING “DAPIRING (Dapivirine) 25mg Vaginal Ring” NCT06250504 ↗
Known as Dapivirina ChEMBL registry synonym — accepted as the source's own label CHEMBL70663 ↗
Known as dapivirine gel 4759 “dapivirine gel 4759, 0.05%, 2.5g applied once daily” NCT00799058 ↗
Known as Dapivirine Gel 4789 “A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4789, 0.05%, 2.5g, a Vaginal Microbicide, Conducted...” NCT00917904 ↗
1

“dapivirine gel 4789, 0.05%, 2.5g applied once daily” NCT00799058 ↗

Known as DPV “We evaluated the safety, pharmacokinetics, and acceptability of a microbicide dapivirine (DPV) vaginal ring (VR) versus placebo in postmenopausal women.” PMID 30289485 ↗ Mar 2019
6

“This study will evaluate the safety and drug detection of the dapivirine (DPV) vaginal ring (VR) and oral Truvada in breastfeeding mother-infant pairs.” NCT04140266 ↗

“Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of HIV-1 infection.” PMID 34118115 ↗ Jun 2021

“containing the active ingredients dapivirine (DPV) and levonorgestrel (LNG), formulated as IPM VR: 200 mg DPV + 320 mg LNG (Ring-102)” NCT03467347 ↗

“Dapivirine (DPV), formulated as vaginal ring, demonstrated HIV risk reduction.” PMID 34498980 ↗ Dec 2021

“Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor” PMID 24070431 ↗ Oct 2013

“Dapivirine (DPV) Vaginal Ring (VR)” NCT03965923 ↗

Known as Gel-02 ChEMBL registry synonym — accepted as the source's own label CHEMBL70663 ↗
Known as R-147681 ChEMBL registry synonym — accepted as the source's own label CHEMBL70663 ↗
Known as TMC120 “candidate microbicide dapivirine (TMC120) for 7 days” NCT00332995 ↗
5

“pharmacokinetics of dapivirine (TMC120) gel” NCT00304642 ↗

“dapivirine (TMC120) vaginal gel” NCT00304668 ↗

“dapivirine (TMC120) vaginal gel” NCT00303576 ↗

“dapivirine (TMC120) vaginal gel” NCT00309205 ↗

NCT00700284 ↗

Action Inhibit “Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor” PMID 24070431 ↗ Oct 2013
Modality Small molecule “Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor” PMID 24070431 ↗ Oct 2013
Route Other “intravaginal gel, dosed daily” NCT00613249 ↗