Trial Outcomes & Findings for Doxycycline for COPD in HIV-Infected Patients (NCT NCT01744093)

Last Updated: 2022-07-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

61 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2022-07-21

Participant Flow

Of the 61 subjects enrolled into the study, 34 subjects did not pass screening.

Participant milestones

Participant milestones
Measure	Doxycycline Doxycycline x 100 mg twice daily (BID orally) for 24 weeks	Placebo (Sugar Pill) One pill twice daily (BID orally) for 24 weeks
Overall Study STARTED	18	9
Overall Study Treated	16	8
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxycycline Doxycycline x 100 mg twice daily (BID orally) for 24 weeks	Placebo (Sugar Pill) One pill twice daily (BID orally) for 24 weeks
Overall Study Withdrawal by Subject	6	1

Baseline Characteristics

Doxycycline for COPD in HIV-Infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxycycline n=18 Participants Doxycycline x 100 mg BID (orally) for 24 weeks	Placebo (Sugar Pill) n=9 Participants Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Doxycycline n=16 Participants Doxycycline x 100 mg BID (orally) for 24 weeks	Placebo (Sugar Pill) n=8 Participants Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks
Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events.	3 Participants	1 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Doxycycline n=16 Participants Doxycycline x 100 mg BID (orally) for 24 weeks	Placebo (Sugar Pill) n=8 Participants Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks
Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: 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.

FEV1 is the volume of air exhaled during the first second of a forced expiratory maneuver.

Outcome measures

Outcome measures
Measure	Doxycycline n=12 Participants Doxycycline x 100 mg BID (orally) for 24 weeks	Placebo (Sugar Pill) n=8 Participants Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks
Clinical: Change in Pulmonary Function (FEV1)	-1.5 Percentage of predicted FEV1 Interval -4.5 to 2.25	1 Percentage of predicted FEV1 Interval -1.75 to 5.0

SECONDARY outcome

Timeframe: 12 Weeks

Population: 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 of MMP-9 activity in bronchoalveolar lavage (BAL) fluid.

Outcome measures

Outcome measures
Measure	Doxycycline n=10 Participants Doxycycline x 100 mg BID (orally) for 24 weeks	Placebo (Sugar Pill) n=7 Participants Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks
Percent Change in BAL MMP-9 Activity	-42 Percent change Interval -62.0 to -28.0	21 Percent change Interval -23.0 to 93.0

SECONDARY outcome

Timeframe: 12 Weeks

Population: 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.

Doxycycline level in serum

Outcome measures

Outcome measures
Measure	Doxycycline n=12 Participants Doxycycline x 100 mg BID (orally) for 24 weeks	Placebo (Sugar Pill) n=7 Participants Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks
Doxycycline Levels	3005 ng/ml Interval 2684.0 to 4179.0	0 ng/ml Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 12 Week

Population: 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.

Doxycycline levels in bronchoalveolar lavage (BAL) fluid.

Outcome measures

Outcome measures
Measure	Doxycycline n=12 Participants Doxycycline x 100 mg BID (orally) for 24 weeks	Placebo (Sugar Pill) n=7 Participants Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks
Doxycycline Levels in BAL	16.75 ng/ml Interval 10.88 to 22.15	0 ng/ml Interval 0.0 to 0.0

Adverse Events

Doxycycline

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo (Sugar Pill)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Doxycycline n=16 participants at risk Doxycycline x 100 mg BID (orally) for 24 weeks.	Placebo (Sugar Pill) n=8 participants at risk Placebo (sugar pill) x 100 mg BID (orally) for 24 weeks.
Infections and infestations Oral thrush	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Blood and lymphatic system disorders Hemoglobin drop	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Gastrointestinal disorders Mouth lesions	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Skin and subcutaneous tissue disorders Excoriated lesions on arms	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	25.0% 2/8 • Number of events 2 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Gastrointestinal disorders Intermittent diarrhea for 4-5 wk	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Skin and subcutaneous tissue disorders Scattered maculopapular rash	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Nervous system disorders Headache	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Respiratory, thoracic and mediastinal disorders Hemoptysis (mild)	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	12.5% 1/8 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Blood and lymphatic system disorders Low absolute neutrophil count	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Musculoskeletal and connective tissue disorders Pain on right side	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
General disorders Tiredness	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	37.5% 3/8 • Number of events 3 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	0.00% 0/8 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.
Renal and urinary disorders Elevated Creatinine	0.00% 0/16 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.	12.5% 1/8 • Number of events 1 • 24 Weeks Clinical assessments included full physical examination at screening, targeted physical examinations at other visits, ongoing assessments for adverse events and new clinical diagnoses and CAT review at each visit. Safety labs were obtained at weeks 2, 6, 12, 18, and 24. 2 participants in the doxycycline arm and 1 participant in the placebo arm were not evaluated for adverse events because they did not take the study drug.

Additional Information

Mei Wang, BS, CCRP

Weill Cornell Medicine

Phone: 646-962-2672

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place