Table 1.
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…)