Ability to stay at the Clinical Center, NIH for a minimum of 4 months, and to 
return to the Clinical Center once monthly for 10 months and at 6 month 
intervals for one year, and then once yearly thereafter 
During the AdCFTR experimental treatment period, ability and agreement to 
remain in the Clinical Center, 7 West ward under appropriate isolation 
conditions, until blood, urine, nasal, pharynx and rectal cultures are 
negative on 3 separate days. Visitors will be limited to individuals 15 years 
or older. 
Evidence in blood of antibodies against adenovirus type 5 
Assessment of airway epithelium demonstrating no evidence of adenovirus type 5 
Ela sequences (see Section 4.9) 
Culture of bronchial brush, nasal brush and bronchoalveolar lavage samples 
demonstrating no evidence of adenovirus, cytomegalovirus, varicella- zoster , 
herpes simplex I and II, influenza viruses A and B, parainfluenza viruses 1, 2 
and 3, or respiratory syncytial virus 
No evidence of replication of AdCFTR DNA upon in vitro infection of 
the patient's respiratory epithelium with AdCFTR (see Section 4.1) 
No anatomic anomalies that would prohibit instillation of the vector 
and recovery of respiratory epithelium as dictated by the protocol 
No history of allergy to glycerol or medications used in the bronchoscopy 
procedure 
No history of documented adenovirus -mediated tracheobronchitis and/or 
pneumonia 
Capable of providing informed consent 
5.4.2 Exclusion criteria 
Unable to meet the inclusion criteria. 
In the 3 weeks prior to beginning the AdCFTR experimental treatment period, no 
evidence of active respiratory tract infection including evidence of fever, 
rhinitis, pharyngitis, conjunctivitis, bronchitis or changes in sputum requir- 
ing antibiotics or a change in antibiotics. If there is evidence of active 
respiratory tract infection, the individual will be discharged (after the 
respiratory tract infection stabilizes) , and the individual reevaluated 4 
weeks later. If all of the inclusion criteria are met, the individual will 
enter the AdCFTR experimental treatment period. 
Evidence of cardiac, renal, central nervous system, major psychiatric 
disorders, musculoskeletal disease or immunodeficiency disease (including 
evidence of human immunodeficiency virus infection) . 
5.5 Safety and Efficacy Parameters 
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