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. Author manuscript; available in PMC: 2018 Dec 1.
Published in final edited form as: Drug Deliv Transl Res. 2017 Dec;7(6):775–795. doi: 10.1007/s13346-017-0385-4

Table 2.

Major findings from recently completed microbicide clinical studies utilizing on-demand products

On-demand product Active Route Purpose Major findings Reference
Gel TFV Rectal Extended safety and acceptability study of TFV reduced-glycerin 1% gel and comparison with oral regimen emtricitabine/TFV disoproxil fumarate Product was safe in MSM and transgender women. Daily gel use was not preferred. Intermittent gel use and oral regimen acceptability was comparable NCT01687218
MTN-017 (Cranston et al. 2016)[15]
MIV-150/PC-1005 Vaginal Safety, PK and acceptability of MV-150 and zinc acetate in a carrageenan (PC-1005) gel Product was well tolerated (14 days use).11/17 participants liked the gel and 7 recommended reducing the volume. CVLs showed activity against HIV and HPV NCT02033109 (Friedland et al. 2016)[16]
Film DPV Vaginal Safety, acceptability, PKPD and comparison with a 0.05% DPV gel for one week daily administration Films were safe and more acceptable than gels. Comparable release between gel and film was seen. Films and gels delivered DPV to tissues in quantities sufficient for ex vivo activity. NCT01548560
FAME-02 (Bunge et al. 2016)[17]
DPV Vaginal PKPD of DPV film and gel in healthy women No severe adverse effects were observed. DPV film showed comparable PK and ex vivo activity as gel NCT01924091
FAME-02B (Robinson et al. 2016)[18]