# Laboratory Center (LC):  Microbicide Trials Network

> **NIH NIH UM1** · MAGEE-WOMEN'S RES INST AND FOUNDATION · 2021 · $2,058,087

## Abstract

The objective of this application is to request an extension of the Microbicide Trials Network (MTN)
Laboratory Center due to delays in completion of studies and analysis related to the COVID-19 pandemic.
The MTN is an HIV/AIDS clinical trials network established to identify safe and effective microbicides for
preventing sexual transmission of HIV in different populations at risk. To accomplish its mission, the MTN
conducts scientifically rigorous, ethically sound and highly efficient clinical studies on the safety,
effectiveness, pharmacokinetics and behavioral aspects associated with microbicide use. The MTN is
comprised of a Leadership and Operations Center (LOG); a Laboratory Center (LC); and a Statistical and
Data Management Center {SDMC). The MTN LC ensures protocols are implemented and followed through
to completion with proper laboratory support. To fulfill the overall MTN agenda the MTN LC works in
cooperation with the MTN LOG and SDMC to provide oversight and coordination of the MTN protocols for
laboratory training, specimen collection/management, specimen testing, and specimen quality control. It
consists of three cores: Protocol Support, Virology and Pharmacodynamics, and Pharmacology. In addition
to supporting laboratory components and analysis for MTN studies, the LC has also provided support in the
form of innovative approaches for product evaluation, specimen collection and testing to ensure product
safety during protocol development. The MTN LC has provided critical input to support regulatory filings
toward licensure of the dapivirine ring. Although the MTN LC was poised for successful completion of its
activities by the end of the grant period, there has been significant interruption of its activities due to the
COVID-19 pandemic. We are requesting a one-year extension for UM1Al106707 MTN Laboratory Center
for successful completion analysis and support for clinical trials which have been interrupted due to the
COVID-19 epidemic. Further, completion of clinical trial activities and sample analysis fulfills obligations for
scientific quality and integrity and ensures that obligations to study participants and communities who have
participated in these trials will be met.

## Key facts

- **NIH application ID:** 10174314
- **Project number:** 4UM1AI106707-08
- **Recipient organization:** MAGEE-WOMEN'S RES INST AND FOUNDATION
- **Principal Investigator:** John W Mellors
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $2,058,087
- **Award type:** 4C
- **Project period:** 2014-01-01 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10174314

## Citation

> US National Institutes of Health, RePORTER application 10174314, Laboratory Center (LC):  Microbicide Trials Network (4UM1AI106707-08). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10174314. Licensed CC0.

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