Status:
COMPLETED
Sildenafil for PNTM Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Nontuberculous Mycobacterial Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: * Pulmonary nontuberculous mycobacterial (PNTM) infection is caused by a common type of bacteria in the environment. Although PNTM infection is most common in people with lung diseases, i...
Detailed Description
Pulmonary nontuberculous mycobacterial (PNTM) infection has increased over the past several decades, especially in older women. No consistent immunological abnormalities have been found despite extens...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adults (18 years of age or older) with PNTM who are currently enrolled on the 01-I-0202 protocol Natural History, Genetics, Phenotype and Treatment of Mycobacterial Infections will be eligible for participation.
- Subjects must have CBF in the range observed in subjects with PNTM (CBF 8.1 plus or minus 1.4 Hz or lower).
- Women of childbearing potential must have a negative pregnancy test result.
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- EXCLUSION CRITERIA:
- Any subject who, in the opinion of the investigator, is unable or unwilling to comply with the study procedures, medication schedule, or study visits.
- Use of nitrate medicines, other PDE inhibitors, or other drugs known to have unsafe interactions with sildenafil.
- Known allergy to sildenafil.
- History of the following:
- Recurrent epistaxis.
- Diabetes or impaired glucose intolerance (risk of retinal hemorrhage with sildenafil is highest in diabetics).
- Portal hypertension.
- Active pulmonary veno-occlusive disease (PVOD).
- Use of daytime oxygen supplementation.
- Unstable or uncontrolled hypertension.
- Active retinopathy, history of retinal detachment, or hemorrhage.
- Initiation of agents known to be potent CYP3A4 inhibitors or inducers (e.g., itraconazole, ritonavir, ketoconazole).
- Any subject who, in the opinion of the investigator, may be at a greater risk of cardiovascular disease or congestive heart failure.
- Breastfeeding.
- Co-Enrollment Guidelines: Subjects will be co-enrolled in the 01-I-0202 protocol. They may also be enrolled in 07-I-0142 entitled Research Respiratory Tract Procedures .Co-enrollment in other trials is restricted, other than enrollment in observational studies or those evaluating the use of a licensed medication. Study staff should be notified of co-enrollment as it may require the approval of the principal investigator.
Exclusion
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01853540
Start Date
January 1 2013
End Date
October 1 2014
Last Update
September 25 2015
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892