Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

Summary

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Timeline

Start

2012-03-27

Primary completion

2016-12-13

Completion

2016-12-13

Outcome

Met primary endpoint

paper The incidence of HIV-1 infection was 31% lower in the dapivirine group than in the placebo group PMID 27959766 ↗

paper hazard ratio, 0.69; 95% confidence interval [CI], 0.49 to 0.99; P=0.04. PMID 27959766 ↗

Publications

• Abaasa AM, Kusemererwa S. Incremental value of non-pharmacokinetic adherence measures for dapivirine vaginal ring use in resource limited setting. Trials. 2026 Jun 11. doi: 10.1186/s13063-026-09838-6. Online ahead of print.
• Kusemererwa S, Ruzagira E, Onyango M, Kabarambi A, Abaasa A. Associations between intravaginal practices and incidence of sexually transmitted infections and bacterial vaginosis among women enrolled in the dapivirine vaginal ring trial (The Ring Study) in southwestern Uganda: a retrospective secondary analysis. BMJ Open. 2024 Apr 8;14(4):e079497. doi: 10.1136/bmjopen-2023-079497.
• Steytler J, Craig C, van der Ryst E, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; Ring Study and the DREAM Trial Study Teams. Characterization of Viruses in Phase 3 and Phase 3b Trials (the Ring Study and the Dapivirine Ring Extended Access and Monitoring Trial) of the Dapivirine Vaginal Ring for Human Immunodeficiency Virus Type 1 Infection Risk Reduction. Clin Infect Dis. 2023 Mar 21;76(6):996-1002. doi: 10.1093/cid/ciac875.
• Kusemererwa S, Abaasa A, Kabarambi A, Onyango M, Mugisha JO. Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda. Sex Transm Infect. 2022 Feb;98(1):32-37. doi: 10.1136/sextrans-2020-054718. Epub 2021 Feb 4.
• Kusemererwa S, Abaasa A, Onyango M, Nel AM, Isaacs M, Asiki G. Contraceptive Preference Among Women at Risk of HIV Acquisition in a Preparatory Screening Study for a Phase III Microbicide Trial in South Western Uganda. AIDS Behav. 2018 Jul;22(Suppl 1):131-138. doi: 10.1007/s10461-018-2177-3.
• Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamali A, Kotze P, Louw C, Mabude Z, Miti N, Kusemererwa S, Tempelman H, Carstens H, Devlin B, Isaacs M, Malherbe M, Mans W, Nuttall J, Russell M, Ntshele S, Smit M, Solai L, Spence P, Steytler J, Windle K, Borremans M, Resseler S, Van Roey J, Parys W, Vangeneugden T, Van Baelen B, Rosenberg Z; Ring Study Team. Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women. N Engl J Med. 2016 Dec 1;375(22):2133-2143. doi: 10.1056/NEJMoa1602046.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dapivirine	Small molecule	25 mg	Other

Indications