Inclusion criteria. 
• Males or females 15 years or older 
• Cystic fibrosis defined by routine clinical criteria, together with a 
positive sweat chloride test and/or a CFTR genotype known to be associ- 
ated with CF. The genotype of mutations of both CFTR alleles (abnormal 
DNA sequences) can be of any type known to be associated with CF with 
exception that individuals with two "null" mutations will be excluded. 
• Sterile and fertile individuals will be included. If there is documented 
sterility in males (semen analysis) and females (documentation of ab- 
sence of uterus and/or ovaries), it will not be necessary to utilize 
birth control measures. If the individual is fertile, they will agree to 
take appropriate birth control measures to prevent pregnancy during the 
course of the study. 
• Lung disease typical of CF, with FEV1 > 1.2 L/sec 
• Shwachman score 40-70 (mild to moderate disease) (15). If there is gas- 
trointestinal or liver disease present, it must be mild and stable with 
appropriate therapy. 
• If diabetes mellitus is present, it must be stable, with no history of 
diabetic ketoacidosis, hyperosmolar coma or hypoglycemia requiring hos- 
pitalization within the previous three years. 
• Demonstrated ability in the control period to undergo fiberoptic bron- 
choscopy with brushing and biopsy of the large airways as necessary for 
the protocol once weekly without significant complications that would 
limit the use of this procedure. 
• Not taking corticosteroids. 
• Not taking experimental medications relevant to lung disease of CF for 
at least 4 weeks prior to entry into the study. 
• Ability to participate for the duration of the study, and to return for 
follow-up studies as outlined in the protocol. 
• During the AdcvCFTR.10 treatment period, ability and agreement to remain 
in the hospital under appropriate isolation conditions, for 2 days after 
administration of the vector. 
• Culture of bronchial brush demonstrating no evidence of current adeno- 
virus infection. 
• 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 the contents of the vehicle used to suspend the 
vector or medications used in the bronchoscopy procedure. 
• Capable of providing informed consent, or in the case of minors (ages 
15-17), the study will be explained as for those *18 years of age, but 
consent will be given by the parent(s) or legal guardian as dictated by 
the regulations of The Rockefeller University Hospital. 
Exclusion criteria 
• Unable to meet the inclusion criteria. 
• In the 3 weeks prior to beginning the AdgvCFTR.10 treatment period, evi- 
dence of active respiratory tract infection including evidence of fever, 
rhinitis, pharyngitis, conjunctivitis, bronchitis or changes in sputum 
requiring 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 AdcvCFTR.10 treatment period. 
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