Trial · NCT01744093
Doxycycline for COPD in HIV-Infected Patients
NCT01744093, Not applicable, Completed, Weill Medical College of Cornell University; results first posted 2018-10-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Doxycycline for COPD in HIV-Infected Patients. Trials, record NCT01744093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01744093
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxycycline for COPD in HIV-Infected Patients
- NCT number
- NCT01744093
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 61 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- HIV, Chronic Obstructive Pulmonary Disease (COPD), Emphysema
- Interventions
- Doxycycline, Placebo (sugar pill)
- First posted
- 2012-12-06
- Last updated
- 2022-07-21
- Results first posted
- 2018-10-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events. | Up to 24 weeks | 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. |
| Primary | Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity | Up to 24 weeks | 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 |
| Secondary | Clinical: Change in Pulmonary Function (FEV1) | 24 Weeks | FEV1 is the volume of air exhaled during the first second of a forced expiratory maneuver. |
| Secondary | Percent Change in BAL MMP-9 Activity | 12 Weeks | Percent change of MMP-9 activity in bronchoalveolar lavage (BAL) fluid. |
| Secondary | Doxycycline Levels | 12 Weeks | Doxycycline level in serum |
| Secondary | Doxycycline Levels in BAL | 12 Week | Doxycycline levels in bronchoalveolar lavage (BAL) fluid. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events. | Up to 24 weeks | 2 subjects were randomized to the doxycycline arm, but withdrew prior to starting the study drug. 1 subject was randomized to the placebo arm, but withdrew prior to starting the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity | Up to 24 weeks | 2 subjects were randomized to the doxycycline arm, but withdrew prior to starting the study drug. 1 subject was randomized to the placebo arm, but withdrew prior to starting the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical: Change in Pulmonary Function (FEV1) | 24 Weeks | At 24 Weeks, total 7 subjects were not analyzed at Week 24. With arm-Doxycycline, 6 subjects dropped out; with arm-Placebo, 1 subject dropped out. | Percentage of predicted FEV1 | MEDIAN |
| SECONDARY | Percent Change in BAL MMP-9 Activity | 12 Weeks | With arm-Doxy, 8 subjects were not analyzed at Week 12 because 5 subjects dropped out, 2 subjects had an inadequate sample, 1 subject could not have the bronchoscopy. With arm-Placebo, 2 subjects were not analyzed at Week 12 because 1 subject dropped out and 1 subject could not have the bronchoscopy. | Percent change | MEDIAN |
| SECONDARY | Doxycycline Levels | 12 Weeks | With arm-Doxy, 6 subjects were not analyzed at Week 12 because 5 subjects dropped out, 1 subject did not provide a sample. With arm-Placebo, 2 subjects were not analyzed at Week 12 because 1 subject dropped out and 1 subject did not provide a sample. | ng/ml | MEDIAN |
| SECONDARY | Doxycycline Levels in BAL | 12 Week | With arm-Doxy, 6 subjects were not analyzed at Week 12 because 5 subjects dropped out, 1 subject could not have the bronchoscopy. With arm-Placebo, 2 subjects were not analyzed at Week 12 because 1 subject dropped out and 1 subject could not have the bronchoscopy. | ng/ml | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events. | Doxycycline | 3 | Participants | ||
| Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events. | Placebo (Sugar Pill) | 1 | Participants | ||
| Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity | Doxycycline | 1 | Participants | ||
| Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity | Placebo (Sugar Pill) | 1 | Participants | ||
| Clinical: Change in Pulmonary Function (FEV1) | Doxycycline | -1.5 | Inter-Quartile Range -4.5 to 2.25 | Percentage of predicted FEV1 | |
| Clinical: Change in Pulmonary Function (FEV1) | Placebo (Sugar Pill) | 1 | Inter-Quartile Range -1.75 to 5 | Percentage of predicted FEV1 | |
| Percent Change in BAL MMP-9 Activity | Doxycycline | -42 | Inter-Quartile Range -62 to -28 | Percent change | |
| Percent Change in BAL MMP-9 Activity | Placebo (Sugar Pill) | 21 | Inter-Quartile Range -23 to 93 | Percent change | |
| Doxycycline Levels | Doxycycline | 3005 | Inter-Quartile Range 2684 to 4179 | ng/ml | |
| Doxycycline Levels | Placebo (Sugar Pill) | 0 | Inter-Quartile Range 0 to 0 | ng/ml |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxycycline | 18 | |
| Overall Study | STARTED | Placebo (Sugar Pill) | 9 | |
| Overall Study | Treated | Doxycycline | 16 | |
| Overall Study | Treated | Placebo (Sugar Pill) | 8 | |
| Overall Study | COMPLETED | Doxycycline | 12 | |
| Overall Study | COMPLETED | Placebo (Sugar Pill) | 8 | |
| Overall Study | NOT COMPLETED | Doxycycline | 6 | |
| Overall Study | NOT COMPLETED | Placebo (Sugar Pill) | 1 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oral thrush | Infections and infestations | Doxycycline | 1 | 16 | 1 |
| other | Oral thrush | Infections and infestations | Placebo (Sugar Pill) | 0 | 8 | 0 |
| other | Hemoglobin drop | Blood and lymphatic system disorders | Doxycycline | 1 | 16 | 1 |
| other | Hemoglobin drop | Blood and lymphatic system disorders | Placebo (Sugar Pill) | 0 | 8 | 0 |
| other | Mouth lesions | Gastrointestinal disorders | Doxycycline | 1 | 16 | 1 |
| other | Mouth lesions | Gastrointestinal disorders | Placebo (Sugar Pill) | 0 | 8 | 0 |
| other | Excoriated lesions on arms | Skin and subcutaneous tissue disorders | Doxycycline | 1 | 16 | 1 |
| other | Excoriated lesions on arms | Skin and subcutaneous tissue disorders | Placebo (Sugar Pill) | 0 | 8 | 0 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Doxycycline | 1 | 16 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo (Sugar Pill) | 2 | 8 | 2 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxycycline | 0 | 16 |
| Total, all-cause mortality | Placebo (Sugar Pill) | 0 | 8 |
| Total, other adverse events | Doxycycline | 13 | 16 |
| Total, other adverse events | Placebo (Sugar Pill) | 6 | 8 |
| Total, serious adverse events | Doxycycline | 0 | 16 |
| Total, serious adverse events | Placebo (Sugar Pill) | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42852919 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R34HL117352 | Doxycycline for COPD in HIV-Infected Patients | KANER, ROBERT J; GLESBY, MARSHALL J | WEILL MEDICAL COLL OF CORNELL UNIV | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2012 to 2013 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Doxycycline vs Placebo (Sugar Pill): Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events. | Trial comparisons |
| Doxycycline vs Placebo (Sugar Pill): Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity | Trial comparisons |
| Doxycycline vs Placebo (Sugar Pill): deaths from any cause | Trial comparisons |
| Doxycycline vs Placebo (Sugar Pill): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01744093
GET https://conductscience.org/api/trials/v1/NCT01744093/events?page=2