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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 1.

Clinical studies currently being pursued using different on-demand products

Product Active Route Status Purpose Reference*
Enema TFV Rectal Phase 1 (recruiting) Safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 formulations of a TFV enema NCT02750540
DREAM-01
Gel DPV Rectal Phase 1 (planned-Mid 2017) Safety, PK and acceptability MTN-026/IPM 038
DPV Rectal Phase 1 (planned-Mid 2017) PK of DPV rectal gel (0.05%) administered via HTI vaginal applicator and a coital simulation device to healthy, HIV-1 uninfected men and transgender women MTN-033/IPM 044
Maraviroc Dual Phase 1 (completed and awaiting results) Compare safety, acceptability and distribution of maraviroc gel against oral maraviroc NCT02346084
CHARM-03
GRFT Vaginal Phase 1 (not open) Safety of GRFT in a carrageenan gel in healthy women NCT02875119
Film TFV Vaginal Phase 0 (awaiting results) Comparative PK of TFV gel and films in healthy women NCT02280109
FAME-05
MB66 Vaginal Phase1 Safety study of monoclonal antibodies to reduce vaginal transmission of HSV and HIV NCT02579083
VAST
Placebo Vaginal Pre-Phase 1 Comparison of acceptability and development of administration guidelines between films of different sizes and tactile properties (Hydroxyethyl cellulose and polyvinyl alcohol films) NCT02908503
FLAG
Hydroxyethyl cellulose
Placebo
Vaginal Pre-Phase 1 Study acceptability of placebo films using objective adherence markers. Note: Other dosage forms, vaginal inserts, gels, and rings are being explored within this study NCT02602366
The Quatro Study
Tablet DS003 Vaginal Phase 1 Evaluate safety and assess local and systemic PK NCT02877979
Insert Placebo Vaginal Phase 1 (results awaiting) Assess disintegration, safety, and acceptability and development of adherence biomarkers (also included are gels, films, and rings) NCT02569697
Placebo Vaginal Phase 1 (results awaiting) Study acceptability of placebo inserts (also films, rings, and gels) using objective adherence markers NCT02602366
The Quatro Study
Suppository Placebo Dual Observational (recruiting) Develop USPE measures for rectal suppositories NCT02744261
DRUM-S
*

More information can be obtained at https://clinicaltrials.gov/ using the clinical trial identifier number (NCT…)