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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 belowSelect...
I am 30 years old or older.
Select...
My chest CT scan shows signs of emphysema.
Select...
I have smoked at least 3 packs of cigarettes per year.
Select...
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:Select...
I am currently on, or might need, dialysis.
Select...
My liver is severely damaged and cannot function properly.
Select...
I have had, or will have, surgery on my lungs or a procedure to place a valve in my airways.
Select...
I have a serious lung condition that is not emphysema or chronic bronchitis.
Select...
I cannot go without supplemental oxygen for 15 minutes.
Select...
I haven't been hospitalized or needed serious treatment in the last 30 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
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 moreSide effects data
From 2022 Phase 4 trial • 449 Patients • NCT040505403%
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
1,569 Previous Clinical Trials
10,314,045 Total Patients Enrolled
University of IowaOTHER
471 Previous Clinical Trials
894,411 Total Patients Enrolled
University of MichiganOTHER
1,863 Previous Clinical Trials
6,441,323 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,536 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,649 Total Patients Enrolled
Marshall J Glesby, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
77 Total Patients Enrolled
Robert J Kaner, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
37 Total Patients Enrolled
Cathie Spino, ScDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
10,344 Total Patients Enrolled