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Tetracycline Antibiotic

Doxycycline for Emphysema in HIV (DEPTH Trial)

Phase 2

Recruiting

Led By Marshall J Glesby, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female age 30 years and older at screening visit

Evidence of emphysema on high resolution CT of the chest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

Awards & highlights

DEPTH Trial Summary

This trial will test if doxycycline can help people with HIV and early stages of emphysema by slowing down the progression of the disease.

Who is the study for?

This trial is for adults over 30 with HIV and emphysema who are current or former smokers. They must have a stable HIV treatment, controlled virus levels, normal liver function tests, no recent serious illnesses or hospitalizations, and not be on certain medications that could interfere with the study.Check my eligibility

What is being tested?

The DEPTH Trial is testing whether doxycycline can slow down the progression of emphysema in people living with HIV. Participants will either receive doxycycline or a placebo to compare effects on lung health, exercise capacity, quality of life, and safety including antibiotic resistance.See study design

What are the potential side effects?

Doxycycline may cause side effects like digestive upset (nausea or diarrhea), sun sensitivity leading to easy sunburns, tooth discoloration if used long term, and possibly an increased risk of yeast infections.

DEPTH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 30 years old or older.

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My chest CT scan shows signs of emphysema.

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I have smoked at least 3 packs of cigarettes per year.

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I can take pills and will follow the study's medication plan.

DEPTH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of decline (slope) of percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (indicated as ppDLCOadj) over the 72 week treatment period.

Secondary outcome measures

Change from baseline to week 48 in 6 minute walk test distance.

Change from baseline to week 48 in St. George's Respiratory Questionnaire (SGRQ) score

Change from baseline to week 48 in forced expiratory volume in 1 second (FEV1) (L)

+19 more

Side effects data

From 2021 Phase 4 trial • 26 Patients • NCT04167085

Sinus infection

Metastatic lung cancer dx

Blurred vision

Foot infection

Emesis

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Doxycycline

Placebo

DEPTH Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DoxycyclineExperimental Treatment1 Intervention

Doxycycline 100mg orally twice a day

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo orally twice a day

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxycycline

2008

Completed Phase 4

~2430

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesOTHER

1,528 Previous Clinical Trials

10,276,601 Total Patients Enrolled

University of IowaOTHER

446 Previous Clinical Trials

879,252 Total Patients Enrolled

University of MichiganOTHER

1,795 Previous Clinical Trials

6,373,686 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this experiment?

"This clinical trial necessitates the participation of 250 qualified patients. Fortunately, two prominent research sites have been identified as recruitment centres; these are located in Pittsburgh and Birmingham respectively."

Answered by AI

In what areas of the city are this clinical investigation being conducted?

"In order to participate, patients must be enrolled at University of Pittsburgh (Pittsburgh, Pennsylvania), University of Alabama at Birmingham (Birmingham, Alabama) or Weill Cornell Medicine (New york, New York). Additionally 8 more sites are offering this trial."

Answered by AI

Is this clinical research recruiting participants at the moment?

"Verified. According to the clinicaltrials.gov resource, this medical experiment is still open for recruitment, having been initially published on July 29th 2022 and recently revised on November 1st 2022."

Answered by AI