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Doxycycline for COPD in HIV-Infected Patients
NA trial testing Doxycycline in HIV in 61 participants. Completed in 30 December 2020.
| Lead sponsor | Weill Medical College of Cornell University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 8 December 2014 |
| Primary completion | 30 June 2017 |
| Estimated completion | 30 December 2020 |
| Sites | 1 location across United States |
Weill Medical College of Cornell University
Adults 18 to 85, any sex, with HIV or Chronic Obstructive Pulmonary Disease (COPD). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To determine the safety of twice daily doxycycline for 24 weeks in HIV-infected subjects with COPD and/or emphysema as measured by the number of subjects with any treatment-related adverse events.
| Group | Value | 95% CI |
|---|---|---|
| Doxycycline | 3 | |
| Placebo (Sugar Pill) | 1 |
To determine the tolerability of twice daily doxycycline for 24 weeks in HIV-infected subjects with COPD and/or emphysema as measured by those subjects experiencing a dose-limiting toxicity
| Group | Value | 95% CI |
|---|---|---|
| Doxycycline | 1 | |
| Placebo (Sugar Pill) | 1 |
FEV1 is the volume of air exhaled during the first second of a forced expiratory maneuver.
| Group | Value | 95% CI |
|---|---|---|
| Doxycycline | -1.5 | -4.5 – 2.25 |
| Placebo (Sugar Pill) | 1 | -1.75 – 5 |
Percent change of MMP-9 activity in bronchoalveolar lavage (BAL) fluid.
| Group | Value | 95% CI |
|---|---|---|
| Doxycycline | -42 | -62 – -28 |
| Placebo (Sugar Pill) | 21 | -23 – 93 |
Doxycycline level in serum
| Group | Value | 95% CI |
|---|---|---|
| Doxycycline | 3005 | 2684 – 4179 |
| Placebo (Sugar Pill) | 0 | 0 – 0 |
Doxycycline levels in bronchoalveolar lavage (BAL) fluid.
| Group | Value | 95% CI |
|---|---|---|
| Doxycycline | 16.75 | 10.88 – 22.15 |
| Placebo (Sugar Pill) | 0 | 00 – 00 |
Time frame: 24 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Doxycycline | Placebo (Sugar Pill) |
|---|---|---|---|
| Tiredness | General disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Oral thrush | Infections and infestations | — | — |
| Hemoglobin drop | Blood and lymphatic system disorders | — | — |
| Mouth lesions | Gastrointestinal disorders | — | — |
| Excoriated lesions on arms | Skin and subcutaneous tissue disorders | — | — |
| Intermittent diarrhea for 4-5 wk | Gastrointestinal disorders | — | — |
| Scattered maculopapular rash | Skin and subcutaneous tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Hemoptysis (mild) | Respiratory, thoracic and mediastinal disorders | — | — |
| Low absolute neutrophil count | Blood and lymphatic system disorders | — | — |
| Pain on right side | Musculoskeletal and connective tissue disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Elevated Creatinine | Renal and urinary disorders | — | — |
Data from ClinicalTrials.gov NCT01744093 adverse events section.
In the context of improved survival from HIV infection itself, chronic obstructive pulmonary disease (COPD); a form of lung disease that includes emphysema, which makes breathing difficult) is emerging as an important cause of morbidity and perhaps ultimately mortality in this population. HIV-infected patients are at increased risk of chronic obstructive pulmonary disease, likely due to multiple factors, including an increased presence of smoking, chronic inflammation and progression of immunodeficiency, oxidant stress (excessive levels of natural chemicals called oxidants and free radicals that can damage tissue), and respiratory infections. While natural history data on COPD are limited in the era of potent antiretroviral therapy, earlier data suggest that the course of emphysema may be accelerated in this population. Our preliminary data suggest that several matrix metalloproteinases (MMPs) derived from alveolar macrophages (a type of immune cell found in the lungs) have an increased cellular response in HIV-infected smokers, which could contribute to accelerated emphysema. Matrix metalloproteinases are enzymes that break down the structural support of tissues, including the airways in the lung. Based on these observations, the investigators hypothesize that pharmacologic inhibition of matrix metalloproteinases by doxycycline will favorably modify the natural history of chronic obstructive pulmonary disease in HIV-infected patients. To test this hypothesis, the investigators propose conducting a proof of concept pilot study as a prelude to a possible phase II randomized, placebo-controlled trial (testing safety and efficacy in a larger population controlled with a "sugar pill") of doxycycline for COPD in HIV-infected patients should the proof of concept be successful. Our research team is lead by a pulmonologist/researcher with expertise in HIV-associated COPD and an infectious diseases specialist/clinical trials expert.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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