Rectal Microbicide Protocol Status

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Presentation transcript:

Rectal Microbicide Protocol Status

Need for Rectal Microbicides Oral PrEP is not for everyone Just as there are choices for contraception based on needs and lifestyles, options are needed for HIV prevention Could be used around the time of sex (instead of daily) Wide range of formulations being developed & tested Gels (with/without an applicator) Enemas Rectal inserts (fast-dissolving rectal tablets) Suppositories Other non-antiretroviral-based products

The Rectal Road 7 drugs and 4 formulations being tested as rectal microbicides (RMs) by MTN and others 2 MTN RM studies underway, 1 expecting results and 2 more launching in 2019

Planned/Ongoing RM Clinical Studies Study Drug Formulation Dose Levels N drug (total) TOX PK PD ACC MTN-026*** DPV Gel (HEC) 1 18(27) √ MTN-035* No API Insert, supp, douche NA (210) MTN-033*** Gel (appl v manual) 16 MTN-037* MIV-150 Gel applicator 3 12 MTN-039** EVG/TAF Insert (tablet) 2 30 DREAM U19** TFV Douche 18 ImQuest U19 IQP 0528 Duogel PREVENT U19 Griffithsin 21 √ *Partnership with Population Council; **Partnership with CONRAD; ***IPM TOX toxicity, PK pharmacokinetics, PD pharmacodynamics, ACC acceptability

Rectal Microbicide Study Timelines Drug Formulation, niche Q3 17 Q4 17 Q1 18 Q2 18 Q3 18 Q4 18 Q1 19 Q2 19 Q3 19 Q4 19 Q1 20 Q2 20 Q3 20 Q4 20 DREAM-01 TFV Douche R4P MTN-026 DPV Appl. Gel CROI IQP DuoGel IQP-0528 MTN-033 Gel +/- Appl. (lube) MTN-037 MIV-150 Appl. Gel, MPT MTN-035 Placebo Douche, Insert, Supp PREVENT GRFT Appl. Gel, luminal MTN-039 EVG/TAF Insert Start (actual) Start (tentative) Ongoing Data Analysis/Presentation

MTN-037 Study Will multi-purpose antiviral achieve target concentrations? Phase I MIV-150 / Carrageenan / Zinc gel Blocks HIV, HSV, & HPV in lab & animals Men & women (cis & transgender) (N=24) Single dose, volume escalation 4 mL to 32 mL Safety, acceptability, drug conc’n, tissue protection Population Council Collaboration (also vaginal product) HIV HSV HPV

MTN-039 Study Is a rectal insert feasible as rectal microbicide? Phase 1 Elvitegravir/TAF insert Men & women (cis & transgender) (N = 20) Single dose at two dose levels Safety, acceptability, drug concentration, biopsy susceptibility to infection CONRAD collaboration (also vaginal product)

Thank You!