# Long Acting Film Technology for Contraception and HIV Prevention (LATCH)

> **NIH NIH R61** · MAGEE-WOMEN'S RES INST AND FOUNDATION · 2020 · $1,317,796

## Abstract

PROJECT ABSTRACT
Several studies (ASPIRE, VOICE) have shown that adherence is paramount to the success of HIV prevention
methods in women. Providing women with options through alternative drug delivery technologies can positively
impact adherence. A compelling strategy includes co-delivery of an anti-HIV agent with a contraceptive agent to
prevent pregnancy. This proposal plans to develop a next generation multipurpose prevention technology (MPT)
film platform for once a month intravaginal administration of the 4'-Ethynyl-2-fluoro-2'-deoxyadenosine (EFdA)
prodrug (EFdA-P) and a progestin (levonorgestrel (LNG) or etonogestrel (ENG)) to achieve the dual goal of
preventing HIV infection and pregnancy. EFdA-P showed increased bioavailability and tissue permeability
compared to the parent EFdA, a highly potent exciting new antiviral drug. This versatile extended release MPT
film platform is intended to provide a discrete, low cost and convenient alternative to women at high risk of HIV
infection and unintended pregnancy.
Recent data from our lab shows that films can deliver an anti-HIV agent in the vagina for up to 1 month even in
the context of menses and sexual intercourse. Using this knowledge and our expertise in the development of
intravaginal films, this proposal will develop a film platform for co-delivery of a progestin (licensed contraceptive
agent) and EFdA-P at a predetermined rate for at least 1 month. MPT films containing EFdA will also be
generated for comparison. The R61 phase of this milestone driven proposal will generate critical preformulation
data for EFdA/EFdA-P and LNG/ENG drug combinations and optimize the MPT film formulation to achieve one-
month delivery of both drugs with desired short-term stability. This phase will also establish the compatibility of
film prototype with vaginal tissue and microbial flora in vitro followed by vaginal retention studies in the non-
human primate (NHP) model. The R61 phase will demonstrate the ability of the MPT film prototype to attain
desired release profiles of both drugs in vivo (NHP model). Using a clearly defined go / no go criteria, a lead
MPT film will be transitioned to the R33 phase. The R33 phase will involve IND-enabling activities including drug-
drug interaction, in vitro transporter and metabolism studies, manufacturing scale up and establishing long-term
stability of the lead MPT film. It will also demonstrate the safety (rat, rabbit, and NHP) and efficacy of the lead
MPT film against SHIV infection in NHP model. It will also confirm the ability of the film to function in the context
of sexual activity and its ability to deliver contraceptive levels of progestin in the NHP model. The successful
completion of proposed work will generate a novel extended release MPT film platform that can be applied to
other drug combinations.

## Key facts

- **NIH application ID:** 9876984
- **Project number:** 5R61AI142687-02
- **Recipient organization:** MAGEE-WOMEN'S RES INST AND FOUNDATION
- **Principal Investigator:** Lisa Cencia Rohan
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,317,796
- **Award type:** 5
- **Project period:** 2019-02-19 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9876984

## Citation

> US National Institutes of Health, RePORTER application 9876984, Long Acting Film Technology for Contraception and HIV Prevention (LATCH) (5R61AI142687-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9876984. Licensed CC0.

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