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] |