Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)

Inclusion Criteria

• •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:
• •1. Mild, moderate, or severe emphysema assessed by central reader(s) at the CT Imaging Core; or
• •2. 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.
• •1. Screening (Visit 1) Pulmonary Function Test meets ATS quality criteria as determined by a central reviewer at the PFT Reading Core (UCLA)
• •2. 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.
• •Documentation of serum alpha-1-antitrypsin level above the lower limit of normal from a test done at any time prior to the Entry/Baseline visit.
• •Provision of signed and dated written informed consent.
• •Stated willingness to adhere to all study procedures and anticipated availability for the duration of the study.
• •Life expectancy \> 2 years in the opinion of the site investigator.
• •Ability to take oral medication and willingness to adhere to the study drug.
• •For individuals of reproductive potential, negative serum or urine pregnancy test with a sensitivity of less than or equal to 25 mIU/mL at the screening visit. This will be repeated at the Entry/Baseline visit.