# 2/2 Doxycycline for Emphysema in People Living with HIV: The DEPTH Trial

> **NIH NIH U24** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2022 · $932,716

## Abstract

The DEPTH trial represents an innovative approach to slowing the progression of emphysema in
people living with HIV (PLWH), a population that has accelerated disease progression for which there is no
targeted therapy. With our CCC collaborators, we propose a phase II, multi-center, randomized, double-blind,
placebo-controlled trial of doxycycline 100 mg po BID to slow the progression of emphysema as quantified by
diffusing capacity for carbon monoxide (DLCO) among PLWH who are current or former smokers. Participants
will be stratified by smoking status (current vs former smoker) and clinical site, utilizing dynamic randomization.
The primary endpoint of the study is the rate of decline (slope) of percent predicted DLco corrected for
hemoglobin, carboxyhemoglobin and barometric pressure over the 72-week treatment period. Our clinical
collaborators have successfully demonstrated the feasibility of this study in their NHLBI-funded pilot study to
test the safety and tolerability of doxycycline in 27 individuals over 24 weeks (NCT 01744093), and have
assembled a group of experienced clinical sites. The DEPTH trial will extend their promising pilot data to a
formal phase II clinical trial.
 An experienced data coordinating center (DCC) with strong statistical leadership and expertise is key in
both design and analysis, particularly when unanticipated issues arise during the conduct of a clinical trial. The
University of Michigan (UM) Statistical Analysis of Biomedical and Educational Research (SABER) unit in a
top-ranked department of biostatistics will serve as DCC, bringing together an experienced group of faculty and
staff in biostatistics, project management, study monitoring, database design and data management, software
development, and research administration. SABER has a strong track record of collaborations with Weill
Cornell Medicine pulmonary team as the clinical coordinating center (CCC). The overarching goal of the UM
DCC is to collaborate with study investigators, the CCC, and NHLBI to enable successful achievement of the
study on time and within budget. We will accomplish these goals through the three specific aims: (1) Enhance
scientific rigor by providing statistical and clinical trials methodological expertise to design, analyze, and
disseminate research findings; (2) Ensure the collection of timely, accurate and reproducible data, and
maximize adherence to the study protocol; and (3) Provide established infrastructure and services for study
administration and operations and for communication among study stakeholders. Our leadership, experience,
and expertise will promote collaborations, encourage scientific productivity, and facilitate timely dissemination
of findings on the benefits of doxycycline in PLWH who have emphysema. We anticipate that upon completion
of this proposed study, our data will support repurposing the inexpensive antibiotic doxycycline, to slow
emphysema progression in PLWH, and demonstrate that it is safe and wel...

## Key facts

- **NIH application ID:** 10490292
- **Project number:** 5U24HL154946-02
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Catherine A Spino
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $932,716
- **Award type:** 5
- **Project period:** 2021-09-17 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10490292

## Citation

> US National Institutes of Health, RePORTER application 10490292, 2/2 Doxycycline for Emphysema in People Living with HIV: The DEPTH Trial (5U24HL154946-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10490292. Licensed CC0.

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