19 completed, 4 withdrawn, 1 recruiting. 16 Phase 1, 9 Phase 2, 6 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 16 | Completed 15, Withdrawn 1 |
| Phase 2 | 9 | Completed 7, Withdrawn 2 |
| Phase 3 | 6 | Completed 3, Withdrawn 2, Recruiting 1 |
Follow Dapivirine: new trials by email Literature Review of Dapivirine trials Research Report on Dapivirine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT APRETUDE (cabotegravir) 600 mg\3 mL, DAPIRING (Dapivirine) 25mg Vaginal Ring, tenofovir disoproxil and emtricitabine - HIV Infections | Phase 3 | Recruiting | Africa Health Research Institute | 2052 | 2024-02-27 | 2026-07-09 |
| Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008 dapivirine - HIV Infections | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 124 | 2022-08-01 | 2024-07-03 |
| Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs Dapivirine (DPV) Vaginal Ring (VR)-004, Truvada Tablet - HIV Infections | Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 394 | 2020-09-24 | 2023-08-04 |
| Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy Dapivirine (DPV) Vaginal Ring (VR), Truvada Tablet - HIV Infections | Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 1104 | 2020-01-09 | 2025-08-12 |
| Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH) Dapivirine, Truvada - HIV-1-infection | Phase 2 | Withdrawn | International Partnership for Microbicides, Inc. | 2017-11-01 | 2017-09-08 | |
| PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel 200 mg of DPV + 320 mg LNG, 200 mg of DPV - HIV Prevention | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 24 | 2017-05-03 | 2018-05-22 |
| To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women Dapivirine Vaginal Ring-004 - HIV Prevention | Phase 3 | Completed | International Partnership for Microbicides, Inc. | 941 | 2016-07-12 | 2022-10-25 |
| Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women Dapivirine - Human Immunodeficiency Virus | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 16 | 2015-02-01 | 2018-03-13 |
| Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women Dapivirine Vaginal Ring, Placebo Vaginal Ring - Human Immunodeficiency Virus | Phase 2 | Completed | International Partnership for Microbicides, Inc. | 96 | 2013-12-01 | 2022-11-03 |
| DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate dapivirine, miconazole - HIV | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 36 | 2012-12-01 | 2017-09-08 |
| A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa Dapivirine, Placebo - HIV Infections | Phase 3 | Withdrawn | International Partnership for Microbicides, Inc. | 2011-07-01 | 2012-06-11 | |
| A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa Dapivirine, Placebo - HIV Infections | Phase 3 | Withdrawn | International Partnership for Microbicides, Inc. | 2011-07-01 | 2012-06-11 | |
| Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures dapivirine, matched placebo, universal placebo - Topical Penile Exposures | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 48 | 2011-03-01 | 2017-09-08 |
| A Safety Study of Dapivirine Vaginal Ring in Africa Dapivirine, Placebo - HIV Infections | Phase 1 / Phase 2 | Completed | International Partnership for Microbicides, Inc. | 280 | 2010-04-01 | 2011-08-02 |
| A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring dapivirine, placebo - HIV Infections | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 45 | 2010-04-01 | 2010-10-06 |
| An Expanded Safety Study of Dapivirine Gel 4759 in Africa dapivirine, placebo - HIV Infections, Acquired Immunodeficiency Syndrome | Phase 1 / Phase 2 | Completed | International Partnership for Microbicides, Inc. | 280 | 2009-11-01 | 2011-09-12 |
| A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States dapivirine 4789, dapivirine gel 4759, Drug placebo - HIV-1 Infections | Phase 1 / Phase 2 | Completed | International Partnership for Microbicides, Inc. | 128 | 2009-07-06 | 2022-10-25 |
| An Expanded Safety Study of Dapivirine Gel 4789 in Africa dapivirine, placebo - HIV Infections, Acquired Immunodeficiency Syndrome | Phase 1 / Phase 2 | Completed | International Partnership for Microbicides, Inc. | 100 | 2009-07-01 | 2011-12-14 |
| A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium dapivirine (TMC120) vaginal gel - HIV Infections, HIV-1 | Phase 1 / Phase 2 | Completed | International Partnership for Microbicides, Inc. | 36 | 2005-12-01 | 2009-09-01 |
| A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel dapivirine (TMC120) vaginal gel - HIV Infections | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 18 | 2005-11-01 | 2006-06-02 |
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HIV Infections (16) · Acquired Immunodeficiency Syndrome (4)
International Partnership for Microbicides, Inc. (21) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · Africa Health Research Institute (1)
South Africa (13) · Malawi (6) · Belgium (5) · United States (5) · Kenya (3) · Rwanda (3) · Tanzania (3) · Uganda (3) · Zimbabwe (3)
Dr Annalene Nel (4) · Zeda Rosenberg, ScD (4) · Annalene Nel (2) · Annelene Nel, PhD (1) · Craig Hoesley, MD (1) · Dianne M Rausch, PHD (1) · Dr Luc Van Bortel (1) · Dr. Luc Van Bortel (1) · Felix Mhlanga, MBChB, MMed (1) · Jen Balkus, PhD, MPH (1) · John Steytler (1) · Katherine Bunge, MD, MPH (1) · Lee Fairlie (1) · Lisa Noguchi, PhD, CNM (1)
PMID 24070431, PMID 26963505, PMID 30289485, PMID 30602513, PMID 33539761, PMID 35289688, PMID 36345569, PMID 38852114, PMID 39808648, PMID 39954697, PMID 40292084, PMID 41173578, PMID 41559582, PMID 41687672
5UM1AI068633-07 (1)