The Griffithsin (GRFT) fast-dissolving insert (FDI) is developed by Population Council. This fast-dissolving vaginal insert is an on-demand HIV prevention product for women and girls, including pregnant and breastfeeding women, designed for over-the-counter distribution as a non-antiretroviral option. Manufacturable in low- and middle-income countries, the safe, discreet, user-controlled, and portable fast-dissolving insert has activity against HIV, HSV-2, and HPV, and may be suitable for over-the-counter distribution. Building on favorable outcomes in animal models, the GRFT FDI will be advanced through pre-clinical studies, production of good manufacturing practice FDIs, and the conduct of Phase 1 trials.
The cabotegravir injectable depot with levonorgestrel product, developed by CONRAD, is a long-acting, biodegradable silica hydrogel injectable depot that delivers two approved active pharmaceutical ingredients with established safety and efficacy, Cabotegravir, for HIV prevention, and Levonorgestrel, for contraception.
The cabotegravir pellet implant with levonorgestrel is a long-acting multipurpose prevention technology implantable product developed by CONRAD combining cabotegravir, for HIV prevention, and levonorgestrel, for contraception, in a biodegradable subdermal pellet system. This product is a low-cost, biodegradable subdermal pellet-type implant system that provides tightly controlled, long-acting sustained release of its payload, is highly tunable, and does not require surgical removal.
The Tenofovir alafenamide/ Elvitegravir (TAF/EVG) Fast Dissolving Insert is developed by CONRAD. After extensive end-user research, a TAF/EVG dual-compartment insert for PrEP or PEP user-controlled, on-demand use and Multipurpose Prevention Technology against HIV and HSV, will be advanced clinically, providing a user-friendly on-demand product. This game-changer product leverages positive results in non-human primate models and Phase 1 clinical trials (CONRAD 146; MTN-039) as well as proven efficacy. This product will be optimized for user-informed packaging. Manufacturing scale-up, production of good manufacturing practice supplies and investigational new drug amendment filing support will enable clinical testing in clinical trial networks such as the HPTN and will be prioritized based on opportunities for in-human clinical trials by other funders.
The non-antiretroviral, non-hormonal intravaginal ring developed by the Oak Crest Institute of Science is a multipurpose prevention technology with a 1-to 3-month duration combining two novel, luminally acting active pharmaceutical ingredients: (1) an anti-viral with unique mechanisms of action against HIV, HSV, and HPV; and (2) a contraceptive and would be a game-changer product for women who desire non-hormonal contraceptives with prevention of HIV and other sexually transmitted infections in a single product. Gathering end-user feedback early in the design phase will be prioritized. First-in-human trials will evaluate the safety and pharmacokinetics of the multipurpose prevention technology.
The multipurpose prevention technology (MPT) vaginal film being developed by the Rohan Pharmaceutics laboratory at the University of Pittsburgh School of Pharmacy and Magee-Womens Research Institute is a product providing monthly protection against HIV acquisition and unintended pregnancy. Building upon their innovative bioerodible vaginal film platform, this MPT product is being developed as a convenient, low-cost option with desirable features that are informed through end-user acceptability research. The product will undergo formulation optimization, preclinical testing (including studies in animal models such as macaques), IND-filing, and clinical testing in women.
The Population Council and partners are advancing the development of a non-hormonal vaginal ring with potential to provide contraception along with broad microbial action against bacterial vaginosis-associated bacteria, HIV, HSV-2, chlamydia, and gonorrhea. This ring will also be designed with the added benefit of promoting vaginal health by helping to maintain optimal vaginal pH and reducing symptoms of bacterial vaginosis.
The proposed product is a fixed-dose combination (FDC) tablet of TDF / FTC / LNG / EE indicated for both the prevention of HIV and pregnancy. The product will be supplied as a 28-count blister compliance pack containing 21 tablets of the fixed-dose combination of TDF, FTC, LNG, and EE (a 3-week supply) plus 7 tablets of FTC and TDF (a 1-week supply).
Silica hydrogel-based long-acting injectable delivering CAB and levonorgestrel for 3-6 months duration. Currently in preclinical development.
First-in-line, ultra-long-acting injectable MPT that offers durable and sustained protection from HIV transmission, high efficacy of contraception, increased user compliance, and the ability to be removed. It consists of a liquid MPT formulation utilizing excipients that form a biodegradable depot after subcutaneous injection (in-situ forming implant (ISFI)).