1. Rectal Microbicide Protocol Status

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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)

8. Thank You!