Value Placebo Film Study - Trial PACTR202310910514895

Timeline & Enrollment

Summary

Topical microbicides are agents designed to prevent or at least substantially reduce the risk of sexual acquisition and transmission of HIV when applied to the genital or rectal mucosa. Vaginal films are an attractive dosing option for topical (vaginal) delivery of anti-HIV drugs. In terms of costs of production and manufacturing, films are relatively inexpensive, scalable, physically and chemically stable, and amenable to a range of active ingredients including combinations of excipients. In terms of use, films are discreet, portable, and easy to store. Vaginal films can deliver fixed doses of pharmacologically active agents with minimal mess or leakage and without an applicator. Due to their small volume, films also generate no significant alterations in innate microbiome as shown in previous clinical evaluation for our FAME program (U19 AI0826391, U19 AI1202492), and incur less dilution of endogenous antiviral or antibacterial properties in vaginal fluids as compared to vaginal gels. Feedback from women in several clinical and focus-group studies – NCT01231763 (FACE)3, NCT02908503 (FLAG)4, NCT02602366 (Quatro)5, PASII6, NCT01334827 (MIST)7,8, NCT01548560 (FAME 02)9, FAME 02B10, NCT02579083 (VAST)11, NCT01989663 (FAME 04)12, NCT02280109 (FAME 05)13, NCT03537092 (FAME 101)14, FAME 102 (unpublished data), NCT04319718 (FAME 103)15, NCT04391036 (FAME 103B)16 – supported the willingness for women to use such products and the advancement and development of vaginal films for discrete HIV prevention.5,6,9-11MATRIX-002 is a randomized trial assessing the acceptability and safety of two vaginal placebo film products that differ in shape. Specifically, the 2x2" films differ with respect to shape of the corners. One film product is square in shape, while the second product has rounded edges on all four corners. These differences may impact product acceptability and usability. The proposed study will evaluate the acceptability, safety, and self-insertion success of these 1-month placebo film products when applied vaginally with and without sex at five clinical sites, one in the United States and four in South Africa, Zimbabwe, and Kenya. Building on the existing evidence base for the quick dissolve and 7-day extended-release films, multiple African sites will participate in MATRIX-002 alongside the US site, affording the opportunity to obtain critical information and feedback from women who have the greatest potential to benefit from access to a range of HIV prevention products. This study of the one-month placebo vaginal film will examine overall satisfaction with the film after using it, multiple components and correlates of acceptability, as well as topics relevant to adherence and preference."

ICD-10 Classifications