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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
Must not have
Current receipt of, or anticipated need to initiate, hemodialysis or peritoneal dialysis
Decompensated cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on, or might need, dialysis.
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My liver is severely damaged and cannot function properly.
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I have had, or will have, surgery on my lungs or a procedure to place a valve in my airways.
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I have a serious lung condition that is not emphysema or chronic bronchitis.
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I cannot go without supplemental oxygen for 15 minutes.
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I haven't been hospitalized or needed serious treatment in the last 30 days.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline to week 48 in St. George's Respiratory Questionnaire (SGRQ) score
Change from baseline to week 48 in the COPD Activity Test (CAT) score
Change from baseline to week 72 in St. George's Respiratory Questionnaire (SGRQ) score
+7 more

Side effects data

From 2022 Phase 4 trial • 449 Patients • NCT04050540
3%
Malaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care Arm
dPEP Intervention Arm

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
~2650

Find a Location

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,565 Previous Clinical Trials
10,262,939 Total Patients Enrolled
University of IowaOTHER
468 Previous Clinical Trials
893,241 Total Patients Enrolled
University of MichiganOTHER
1,855 Previous Clinical Trials
6,434,811 Total Patients Enrolled
~123 spots leftby Feb 2027
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