# An Etonogestrel/Ethinyl Estradiol/QGriffithsin (ETG/EE/QGRFT) IVR to Prevent Pregnancy and HIV

> **NIH NIH R01** · POPULATION COUNCIL · 2021 · $994,388

## Abstract

An Etonogestrel/Ethinyl Estradiol/QGriffithsin (EEQ) IVR to Prevent Pregnancy and HIV
Several multipurpose prevention technologies (MPTs) have been advanced to prevent unintended pregnancy
and HIV. The current MPT development pipeline is dominated by antiretroviral (ARV) products with progestin-
only contraception using levonorgestrel. The Population Council, in collaboration with Oak Crest Institute of
Science (OCIS), proposes to develop a 90d pod-type IVR containing the progestin etonogestrel (ETG), the
estrogen ethinyl estradiol (EE), and the anti-HIV lectin QGriffithsin (QGRFT), hereafter referred to as the EEQ
IVR, to prevent unintended pregnancy and HIV. This product offers a highly effective contraceptive
combination (used in NuvaRing®) with the extremely potent and stable non-ARV anti-HIV lectin QGRFT. The
EEQ IVR offers significant advantages over ARV/progestin-only contraceptive products. It could reduce both
the emergence of drug-resistant HIV and the concern of potential increased risk of HIV transmission as well as
common irregular bleeding complaints associated with use of a progestin-only contraceptive. Aim 1: The
proposed product development plan for the EEQ IVR includes innovative formulation work involving pod IVR
designs and the use of silk fibroin to achieve QGRFT release for 90d. We will develop a scalable process to
manufacture an EEQ IVR. Aim 2: Two lead EEQ IVRs will be tested in
safety/pharmacokinetics/pharmacodynamics studies in rhesus macaques (RMs). We intend that the EEQ IVR
will be safe, deliver target API doses for 90d in vivo and demonstrate in vitro efficacy against HIV/SHIV AD8.
Based on these studies, the lead RM IVR will be selected and advanced to in vivo efficacy studies in RMs. We
postulate that the EEQ IVR will be efficacious against SHIV AD8 in vivo and will not drive resistance. Aim 3:
We will conduct a pilot study among 24 US couples to compare adherence, preference and acceptability of 3
placebo silicone IVRs of different external diameters (46mm, 56mm and 66mm) to inform the design of the
EEQ IVR. Using a 3-way crossover study design, we will identify the external IVR diameter associated with
greatest adherence and preference to inform the final EEQ IVR design. The EEQ IVR has the potential to
significantly improve women’s health and advance the MPT and drug delivery fields. The EEQ IVR would be
the first non-ARV MPT for women at high risk for both unintended pregnancy and HIV acquisition.

## Key facts

- **NIH application ID:** 10138979
- **Project number:** 5R01AI150360-02
- **Recipient organization:** POPULATION COUNCIL
- **Principal Investigator:** Nina R. Derby
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $994,388
- **Award type:** 5
- **Project period:** 2020-04-06 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10138979

## Citation

> US National Institutes of Health, RePORTER application 10138979, An Etonogestrel/Ethinyl Estradiol/QGriffithsin (ETG/EE/QGRFT) IVR to Prevent Pregnancy and HIV (5R01AI150360-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10138979. Licensed CC0.

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