# Evaluating Antiretroviral Pharmacology in the Female Genital Tract to Optimize HIV Prevention

> **NIH NIH K08** · UNIVERSITY OF MINNESOTA · 2020 · $169,355

## Abstract

Project Summary/Abstract
The HIV epidemic continues to present a significant global burden. Although they represent half
of the global epidemic, development of effective prevention strategies for women has been
slow. Tenofovir-based pre-exposure prophylaxis has demonstrated success in reducing HIV
infections however two failed clinical trials have raised concern about effectiveness in women.
Host factors such as inflammation, hormones, and the vaginal microbiome may modulate not
only HIV risk, but drug efficacy as well. In this career development award, advanced training will
be obtained in the techniques and approaches required to develop an independent scientist
proficient in performing the translational studies required to better elucidate the complex
mucosal environment of the female genital tract. This research proposal will lay the ground work
studies characterizing the effect of hormones, inflammation, and the vaginal microbiome on
drug exposure and efficacy in cervical tissues. Active metabolites of tenofovir and other
nucleotide analogues will be measured in cervical biopsies from HIV positive women from U.S.
and Ugandan cohorts receiving hormonal contraception. Quantification of pro-inflammatory
cytokines and 16S DNA sequencing will be performed in swabs to assess inflammation and the
vaginal microbiome of these women. Ex vivo tissue models will be used to determine
associations between inflammation, nucleotide analogue activation, and viral inhibition.
Completion of these research aims, with the guidance of an interdisciplinary mentoring team,
will be supplemented by advanced coursework and workshops in statistics, immunology,
microbiomics, and research ethics. This research and training plan are designed to result in the
preliminary data and developed expertise necessary to prepare for an R01 submission
elucidating the complex interplay between hormones, microbiome, inflammation, drug
disposition, target cell expression, and drug potency in the female genital tract.

## Key facts

- **NIH application ID:** 9848498
- **Project number:** 5K08AI134262-03
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** Melanie Rae Nicol
- **Activity code:** K08 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $169,355
- **Award type:** 5
- **Project period:** 2018-02-05 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9848498

## Citation

> US National Institutes of Health, RePORTER application 9848498, Evaluating Antiretroviral Pharmacology in the Female Genital Tract to Optimize HIV Prevention (5K08AI134262-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9848498. Licensed CC0.

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