Eligibility
18+
All Sexes
What conditions do you have?
Select
Study 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.
Eligible Conditions
- Emphysema
- HIV
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 22 Secondary · Reporting Duration: 72 weeks
48 weeks
Change from baseline to week 48 in 6 minute walk test distance.
Change from baseline to week 48 in St. George's Respiratory Questionnaire (SGRQ) score
Change from baseline to week 48 in forced expiratory volume in 1 second (FEV1) (L)
Change from baseline to week 48 in percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (ppDLCOadj).
Change from baseline to week 48 in the COPD Activity Test (CAT) score
Change from baseline to week 48 in the ratio of forced expiratory volume in 1 second and forced vital capacity (FEV1/FVC)
72 weeks
Change from baseline to week 72 in 6 minute walk test distance.
Change from baseline to week 72 in St. George's Respiratory Questionnaire (SGRQ) score
Change from baseline to week 72 in forced expiratory volume in 1 second (FEV1) (L)
Change from baseline to week 72 in percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (ppDLCOadj).
Change from baseline to week 72 in percentage of voxels < -950 Hounsfield Units (HU)
Change from baseline to week 72 in the COPD Activity Test (CAT) score
Change from baseline to week 72 in the ratio of forced expiratory volume in 1 second and forced vital capacity (FEV1/FVC)
Rate of decline (slope) of percent predicted diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin, carboxyhemoglobin and barometric pressure (indicated as ppDLCOadj) over the 72 week treatment period.
The number of adverse events
The number of participants permanently discontinuing study medication due to adverse events.
The number of participants with development of culture proven antibiotic-resistant bacterial infection with reduced susceptibility or resistance to doxycycline (adverse event of special interest).
The number of serious adverse events.
The proportion of participants permanently discontinuing study medication due to adverse events.
The proportion of participants with at least 1 adverse event
The proportion of participants with at least 1 serious adverse event.
The proportion of participants with deaths.
The proportion of participants with development of culture proven antibiotic-resistant bacterial infection with reduced susceptibility or resistance to doxycycline (adverse event of special interest).
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Doxycycline
4%Foot infection
4%Metastatic lung cancer dx
4%Sinus infection
4%Blurred vision
4%Emesis
4%Pneumonia
0%GI bleeding
0%Flu-like symptoms
0%Pneumonia hospitalization
0%Throat infection
0%Prolonged nosebleed requiring cauterization
0%Allergy-like symptoms
Trial Design
2 Treatment Groups
Doxycycline
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
250 Total Participants · 2 Treatment Groups
Primary Treatment: Doxycycline · Has Placebo Group · Phase 2
Doxycycline
Drug
Experimental Group · 1 Intervention: Doxycycline · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
2008
Completed Phase 4
~2600
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 weeks
Closest Location: University of Pittsburgh · Pittsburgh, PA
2004First Recorded Clinical Trial
6 TrialsResearching Emphysema
647 CompletedClinical Trials
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,555 Previous Clinical Trials
46,914,939 Total Patients Enrolled
23 Trials studying Emphysema
20,502 Patients Enrolled for Emphysema
University of IowaOTHER
400 Previous Clinical Trials
786,565 Total Patients Enrolled
1 Trials studying Emphysema
2,981 Patients Enrolled for Emphysema
University of California, Los AngelesOTHER
1,381 Previous Clinical Trials
6,520,897 Total Patients Enrolled
6 Trials studying Emphysema
3,325 Patients Enrolled for Emphysema
University of MichiganOTHER
1,597 Previous Clinical Trials
6,328,807 Total Patients Enrolled
1 Trials studying Emphysema
2,981 Patients Enrolled for Emphysema
Weill Medical College of Cornell UniversityLead Sponsor
973 Previous Clinical Trials
1,351,264 Total Patients Enrolled
4 Trials studying Emphysema
548 Patients Enrolled for Emphysema
Cathie Spino, ScDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
10,700 Total Patients Enrolled
Marshall J Glesby, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
77 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are a current or former smoker.
You have HIV-1 RNA level < 200 copies/ml within 90 days prior to the Entry/Baseline visit by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.
You have elevated serum ALT and/or AST levels within 45 days prior to the Entry/Baseline visit.
You are 30 years of age or older.\n
The patient must have evidence of emphysema on HRCT.
DLCO < LLN by the Global Lung Initiative (GLI) predicted set for DLCO adjusted for barometric pressure, hemoglobin and carboxyhemoglobin based on the mean of screening and pre-entry measurements.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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