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Doxycycline for COPD in HIV-Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744093
Recruitment Status : Active, not recruiting
First Posted : December 6, 2012
Results First Posted : October 10, 2018
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions HIV
Chronic Obstructive Pulmonary Disease (COPD)
Emphysema
Interventions Drug: Doxycycline
Drug: Placebo (sugar pill)
Enrollment 61
Recruitment Details  
Pre-assignment Details Of the 61 subjects enrolled into the study, 34 subjects did not pass screening.
Arm/Group Title Doxycycline Placebo (Sugar Pill)
Hide Arm/Group Description Doxycycline x 100 mg twice daily (BID orally) for 6 months Placebo (sugar pill) x 100 mg twice daily (BID orally) for 6 months
Period Title: Overall Study
Started 18 9
Completed 12 8
Not Completed 6 1
Arm/Group Title Doxycycline Placebo (Sugar Pill) Total
Hide Arm/Group Description Doxycycline x 100 mg BID (orally) for 6 months Placebo (sugar pill) x 100 mg BID (orally) for 6 months Total of all reporting groups
Overall Number of Baseline Participants 18 9 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 9 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
9
 100.0%
27
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 9 participants 27 participants
Female
5
  27.8%
1
  11.1%
6
  22.2%
Male
13
  72.2%
8
  88.9%
21
  77.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 9 participants 27 participants
Hispanic or Latino
2
  11.1%
0
   0.0%
2
   7.4%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
16
  88.9%
9
 100.0%
25
  92.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 9 participants 27 participants
American Indian or Alaska Native
2
  11.1%
0
   0.0%
2
   7.4%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  55.6%
7
  77.8%
17
  63.0%
White
4
  22.2%
2
  22.2%
6
  22.2%
More than one race
2
  11.1%
0
   0.0%
2
   7.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 9 participants 27 participants
18
 100.0%
9
 100.0%
27
 100.0%
1.Primary Outcome
Title Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events.
Hide Description To determine the safety of twice daily doxycycline for 6 months in HIV-infected subjects with COPD and/or emphysema as measured by the number of subjects with any treatment-related adverse events.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Placebo (Sugar Pill)
Hide Arm/Group Description:
Doxycycline x 100 mg BID (orally) for 6 months
Placebo (sugar pill) x 100 mg BID (orally) for 6 months
Overall Number of Participants Analyzed 18 9
Measure Type: Count of Participants
Unit of Measure: Participants
3
  16.7%
1
  11.1%
2.Primary Outcome
Title Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity
Hide Description To determine the tolerability of twice daily doxycycline for 6 months in HIV-infected subjects with COPD and/or emphysema as measured by those subjects experiencing a dose-limiting toxicity
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxycycline Placebo (Sugar Pill)
Hide Arm/Group Description:

100 mg twice daily (BID orally) x 6 months

Doxycycline: 100 mg twice daily (BID orally) x 6 months

100 mg twice daily (BID orally) x 6 months

Placebo (sugar pill): 100 mg twice daily (BID orally) x 6 months

Overall Number of Participants Analyzed 18 9
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
1
  11.1%
3.Secondary Outcome
Title Biologic Effects, as Measured by Levels of MMP Activity in Epithelial Lining Fluid Before and After Study Drug Administration
Hide Description Reduction of MMP activity in epithelial lining fluid and cells obtained by bronchoscopy and doxycycline levels in blood, ELF and bronchoalveolar lavage (BAL) cell pellets; change in FEV1.
Time Frame 12 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Physiologic Effects, as Measured by Levels of MMP Activity in Epithelial Lining Fluid Before and After Study Drug Administration.
Hide Description Reduction of MMP activity in epithelial lining fluid and cells obtained by bronchoscopy and doxycycline levels in blood, ELF and bronchoalveolar lavage (BAL) cell pellets; change in FEV1.
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame 24 Weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Doxycycline Placebo (Sugar Pill)
Hide Arm/Group Description Doxycycline x 100 mg BID (orally) for 6 months. Placebo (sugar pill) x 100 mg BID (orally) for 6 months.
All-Cause Mortality
Doxycycline Placebo (Sugar Pill)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
Doxycycline Placebo (Sugar Pill)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxycycline Placebo (Sugar Pill)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/18 (16.67%)      1/9 (11.11%)    
Blood and lymphatic system disorders     
Hemoglobin drop   1/18 (5.56%)  1 0/9 (0.00%)  0
Gastrointestinal disorders     
Mouth lesions   1/18 (5.56%)  1 0/9 (0.00%)  0
Diarrhea   1/18 (5.56%)  2 0/9 (0.00%)  0
Infections and infestations     
Oral thrush   1/18 (5.56%)  1 0/9 (0.00%)  0
Renal and urinary disorders     
Elevated creatinine   0/18 (0.00%)  0 1/9 (11.11%)  2
Skin and subcutaneous tissue disorders     
Maculopapular rash   1/18 (5.56%)  1 0/9 (0.00%)  0
Excoriated lesions on arms   1/18 (5.56%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Grace W. Mammen, BA, CCRP
Organization: Weill Cornell Medicine
Phone: 646-962-2672
EMail: gwm2004@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01744093    
Other Study ID Numbers: 1208012780
R34HL117352 ( U.S. NIH Grant/Contract )
First Submitted: November 20, 2012
First Posted: December 6, 2012
Results First Submitted: August 31, 2018
Results First Posted: October 10, 2018
Last Update Posted: October 22, 2019