Trials / Active Not Recruiting
Active Not RecruitingNCT05382208
Doxycycline for Emphysema in People Living With HIV (The DEPTH Trial)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Weill Medical College of Cornell University · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial in approximately 250 people living with HIV who have emphysema. Eligible participants will be randomized in a 1:1 fashion to doxycycline or placebo. Participants will receive 100 mg doxycycline orally or matched placebo twice a day for 72 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Doxycycline | Doxycycline 100 mg orally twice a day. |
| DRUG | Placebo | Matching placebo orally twice a day. |
Timeline
- Start date
- 2022-08-22
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2022-05-19
- Last updated
- 2026-01-26
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05382208. Inclusion in this directory is not an endorsement.