40 completed, 6 withdrawn. 35 Phase 1, 10 Phase 2, 5 Phase 3, 1 Early Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 35 | Completed 32, Withdrawn 3 |
| Phase 2 | 10 | Completed 8, Withdrawn 2 |
| Phase 3 | 5 | Completed 3, Withdrawn 2 |
| Early Phase 1 | 1 | Completed 1 |
| Not applicable | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel IPM Ring-105, IPM Ring-106 - Pharmacokinetics, Safety Issues | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 40 | 2022-06-20 | 2026-04-01 |
| PK Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel VR: 200 mg DPV + 320 mg LNG - Healthy, Contraception | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 25 | 2018-07-17 | 2019-10-09 |
| A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings Dapivirine Vaginal Ring, 25 mg, Dapivirine Vaginal Ring, 100 mg, Dapivirine Vaginal Ring, 200 mg - HIV-1-infection | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 49 | 2017-12-04 | 2019-01-29 |
| 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the Epidemic in Africa With Choices in HIV Prevention (REACH) Dapivirine, Truvada - HIV-1-infection | Phase 2 | Withdrawn | International Partnership for Microbicides, Inc. | 2017-11-01 | 2017-09-08 | |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 |
| Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women Dapivirine Vaginal Ring - Human Immunodeficiency Virus | Phase 3 | Completed | International Partnership for Microbicides, Inc. | 1456 | 2016-07-18 | 2022-10-25 |
| 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 |
| Evaluate the Safety & Assess Local and Systemic PK of DS003 Vaginal Tablets Administered to Healthy HIV-negative Women DS003 vaginal tablet, Placebo - HIV | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 36 | 2015-11-18 | 2017-08-24 |
| Dapivirine Gel Rectal Safety and PK Study Dapivirine gel (0.05%), Universal HEC placebo gel - HIV 1 Infection | Phase 1 | Withdrawn | International Partnership for Microbicides, Inc. | 2015-09-29 | 2017-02-08 | |
| To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%) Dapivirine Ring-004, Dapivirine Ring-004 for 28 days along with clotrimazole, Clotrimazole - HIV- Prevention | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 36 | 2015-09-01 | 2017-08-30 |
| 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 |
| 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 Dapivirine Vaginal Ring-004 and no tampons, Dapivirine Vaginal Ring-004 with tampons, Dapivirine Vaginal Ring-004 with no menses - HIV | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 16 | 2015-01-12 | 2017-09-06 |
| Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV) - HIV/AIDS | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 19 | 2015-01-01 | 2017-09-08 |
| Study of Dapivirine Vaginal Ring (VR) in Adolescents placebo ring, dapivirine ring - Human Immunodeficiency Virus | Phase 2 | Completed | International Partnership for Microbicides, Inc. | 96 | 2014-06-27 | 2022-10-24 |
| 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 |
| Expanded Use PK of Dapivirine Vaginal Ring dapivirine ring - Pharmacokinetics | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 40 | 2013-11-01 | 2016-08-26 |
| PK/PD of Single Dose Dapivirine Vaginal Film Dapivirine gel, Dapivirine film - Pharmaokinetics | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 60 | 2013-09-01 | 2017-09-08 |
| A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring Silicone Elastomer Vaginal Ring, Female Condom - Human Immunodeficiency Virus | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 160 | 2013-08-01 | 2017-09-28 |
| Functionality of Male Condoms With a Silicone Elastomer Vaginal RIng Placebo Vaginal Ring, Condom - Human Immunodeficiency Virus | Phase 1 | Completed | International Partnership for Microbicides, Inc. | 70 | 2013-02-01 | 2018-03-29 |
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HIV Infections (24) · Acquired Immunodeficiency Syndrome (9) · Contraception Behavior (1) · Hemorrhage (1)
Dapivirine (21) · Vaginal Creams, Foams, and Jellies (4) · Contraceptive Devices, Female (3) · Maraviroc (2) · Adenine (1) · Clotrimazole (1) · Condoms (1) · Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (1) · Gels (1) · Levonorgestrel (1) · Miconazole (1) · Single-Use Internal Condom (1) · Tablets (1)
United States (16) · South Africa (15) · Belgium (8) · Malawi (6) · Rwanda (4) · Tanzania (4) · Uganda (4) · Kenya (3) · Zimbabwe (3) · Dominican Republic (1)
Dr Annalene Nel (4) · Zeda Rosenberg, ScD (4) · Annalene Nel (3) · Dr. Annalene Nel (3) · John Steytler (2) · Annalene Nel, PhD (1) · Annelene Nel, PhD (1) · Beatrice A Chen, MD, MPH (1) · Craig Hendrix, MD (1) · Craig Hoesley, MD (1) · Dianne M Rausch, PHD (1) · Dr Luc Van Bortel (1) · Dr. Luc Van Bortel (1) · Ian McGowan, MD, PhD, FRCP (1)
PMID 36345569, PMID 39808648, PMID 22039430, PMID 24070431, PMID 26900902, PMID 26963505, PMID 27959766, PMID 29855975, PMID 30218318, PMID 30289485, PMID 30346511, PMID 30602513, PMID 30816632, PMID 31306167, PMID 31929401, PMID 32920652, PMID 33539761, PMID 33539762, PMID 33542153, PMID 33713213, PMID 33892693, PMID 34101626, PMID 34118115, PMID 34384282, PMID 34969254, PMID 35289688, PMID 35344520, PMID 36189636, PMID 38099506, PMID 38589266, PMID 38852114, PMID 42277878
5UM1AI068633 (2), 5UM1AI068633-07 (1), UM1AI068633-06 (1)