Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
DEPTH
3 other identifiers
interventional
133
1 country
20
Brief Summary
The purpose of this study is to determine if doxycycline will reduce progression of emphysema in people living with HIV. The secondary objectives are to examine the effects of doxycycline on change in quantity of emphysema, six minute walk distance, patient reported outcomes, ratio of forced expiratory volume in 1 second and forced vital capacity. Secondary objectives will also describe the safety and tolerability of doxycycline and determine if doxycycline is associated with development of antibiotic-resistant bacterial infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2022
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedStudy Start
First participant enrolled
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
January 26, 2026
January 1, 2026
4.4 years
May 16, 2022
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
72 weeks
Secondary Outcomes (22)
Change from baseline to week 48 in 6 minute walk test distance.
48 weeks
Change from baseline to week 72 in 6 minute walk test distance.
72 weeks
Change from baseline to week 48 in percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (ppDLCOadj).
48 weeks
Change from baseline to week 72 in percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (ppDLCOadj).
72 weeks
Change from baseline to week 72 in percentage of voxels < -950 Hounsfield Units (HU)
72 weeks
- +17 more secondary outcomes
Study Arms (2)
Doxycycline
EXPERIMENTALDoxycycline 100mg orally twice a day
Placebo
PLACEBO COMPARATORMatching placebo orally twice a day
Interventions
Eligibility Criteria
You may qualify if:
- Male or female age 30 years and older at screening visit.
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to the enrollment visit, and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
- Current or former smoker with at least a 3 pack-year history of cigarette smoking at screening visit.
- Evidence of emphysema on high resolution CT (HRCT) of the chest done at pre-entry visit (Visit 2). Emphysema is defined as either:
- Mild, moderate, or severe emphysema assessed by central reader(s) at the CT Imaging Core; or
- Quantification of ≥ 5% of voxels with density \< -950 Hounsfield Units (HU) as quantified by the CT Imaging Core.
- All participants with emphysema by either or both criteria must have ≤ 35% of voxels with density \< -950 HU.
- Screening and Entry DLCO measurements must be within 15% of each other. The PFT quality at both visits must be acceptable based on ATS Quality Criteria.
- Screening (Visit 1) Pulmonary Function Test meets ATS quality criteria as determined by a central reviewer at the PFT Reading Core (UCLA)
- Baseline (Visit 2) Pulmonary Function Test meets ATS quality criteria as determined by the central reviewer at the PFT Reading Core (UCLA), Site Investigator, or DEPTH Trial Leadership.
- HIV-1 RNA level \< 200 copies/ml within 90 days prior to the Entry/Baseline visit by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.
- CD4 cell count \> 100 cells/mm3 within 90 days prior to the Entry/Baseline visit.by any US laboratory that has a CLIA certification or its equivalent.
- Stable antiretroviral therapy for greater than or equal to 8 weeks prior to the Entry/Baseline visit. Substitutions of one formulation of a drug for another are not considered changes in antiretroviral therapy for the purpose of defining stable therapy..
- Serum ALT and AST \< 3 x upper limit of normal within 60 days prior to the Entry/Baseline visit.
- Participants on therapy for COPD must be on stable therapy for at least 4 weeks prior to the Entry/Baseline visit.
- +6 more criteria
You may not qualify if:
- Pulmonary infection, acute COPD exacerbation, acute opportunistic infection within 30 days prior to the Screening Visit 1 or Entry/Baseline Visit 2.
- Any acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to the Entry/Baseline visit.
- Decompensated cirrhosis defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage.
- History of, or planned, wedge resection, lobectomy, pneumonectomy, or lung volume reduction surgery.
- History of, or planned, endobronchial valve placement for lung volume reduction.
- Significant parenchymal lung disease other than emphysema or chronic bronchitis (e.g. sarcoidosis, MAI infection, pulmonary fibrosis, lung cancer, bullae/cysts from prior Pneumocystis pneumonia) that would preclude accurate quantification of emphysema.
- Previous allergy or intolerance to doxycycline or other drugs in the tetracycline class (e.g. minocycline, tetracycline).
- Breastfeeding individuals.
- Receipt of any investigational\* drug within 30 days prior to the Entry/Baseline visit. Note: for the purpose of this protocol, investigational drug refers to a drug that is not FDA approved for any indication. COVID vaccines available under emergency use authorization are allowed.
- Need for concomitant use of barbiturates; carbamazepine; phenytoin
- Use of systemic retinoids (eg. Isotretinoin \[Accutane\]) or Vitamin A within 30 days prior to the Entry/Baseline visit. Note: Multivitamin containing Vitamin A use is permitted.
- Use of any systemic antibiotic (e.g., doxycycline or other tetracycline, azithromycin) within 7 days prior to the Entry/Baseline visit.
- Any condition including active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- History of recurrent C. difficile infection or C. difficile infection within 30 days prior to the Entry/Baseline visit.
- Inability to stop supplemental oxygen for 15 minutes to perform a DLCO maneuver.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angelescollaborator
- Weill Medical College of Cornell Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Iowacollaborator
- University of Michigancollaborator
Study Sites (20)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
University of California San Diego
San Diego, California, 92103, United States
Miami University
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30329, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
SUNY Downstate Medical School
Brooklyn, New York, 11203, United States
Weill Cornell Medicine
New York, New York, 10065, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Duke University School of Medicine
Durham, North Carolina, 27704, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
Case Western University
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43210, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
University of Texas, McGovern Medical School
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marshall J Glesby, MD, PhD
Weill Medical College of Cornell University
- PRINCIPAL INVESTIGATOR
Cathie Spino, ScD
University of Michigan
- PRINCIPAL INVESTIGATOR
Robert J Kaner, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The participant and site personnel will not know which study treatment the participant is receiving.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2022
First Posted
May 19, 2022
Study Start
August 22, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Study data will be shared through the NHLBI data repository, no later than 3 years after the end of the study or 2 years after the main paper reporting the results of the trial, whichever comes first.
- Access Criteria
- Data will be shared through the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).
The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with NHLBI data sharing policies.