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

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.

Timeline

Start

2017-10-26

Primary completion

2018-09-20

Completion

2018-09-20

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (superiority test); Dapivirine Gel vs Placebo Gel; p = 0.072; Fisher Exact NCT03239483 ↗

Publications

• Bauermeister JA, Tingler RC, Dominguez C, Dunne EF, Hoesley C, Ho K, Johnson S, Lucas J, Macagna N, Brown E, Gundacker H, Peda M, Jacobson CE, Kramzer L, Singh D, Dezzutti CS, Ayudhya RPKN, Marzinke MA, Piper J, Devlin B, Nuttall J, McGowan I, Hendrix CW, Cranston RD; MTN 026 team. Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026). AIDS Behav. 2022 May;26(5):1333-1346. doi: 10.1007/s10461-021-03490-8. Epub 2021 Oct 17.
• Cranston RD, Brown E, Bauermeister J, Dunne EF, Hoesley C, Ho K, Johnson S, Lucas J, Dominguez-Islas C, Gundacker H, Peda M, Jacobson CE, Kramzer L, Singh D, Dezzutti CS, Kunjara Na Ayudhya RP, Brand RM, Wang L, Marzinke MA, Piper J, Devlin B, Nuttall J, McGowan I, Hendrix CW. A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety, and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults (MTN-026). AIDS Res Hum Retroviruses. 2022 Apr;38(4):257-268. doi: 10.1089/AID.2021.0071. Epub 2021 Dec 6.

Drugs

Indications