5.0 
PATIENT ELIGIBILITY 
5.1 Inclusion Criteria 
5.1.1 Male or female subjects > 18 years of age. 
5.1.2 Mild to moderate lung disease; forced vital capacity > 60% predicted and 
Shwachman-Kulczycki score >65. 
5.1.3 Sweat chloride > 60 meq/liter 
5.1.4 CF genotype: AF508 homozygotes or patients heterozygous for AF508 and 
another mutation associated with pancreatic insufficiency. 
5.2 Exclusion Criteria 
5.2.1 Recent (within the preceding 30 days) hospitalization or home intravenous 
antibiotic therapy for a pulmonary exacerbation. 
5.2.2 Sputum colonization with Pseudomonas cepacia or another multiply 
resistant organism. 
5.2.3 Recurrent or intermittent hemoptysis, to include a bout of significant 
hemoptysis requiring transfusion or embolization within the past year or 
coughing of >30 cc of blood more often than one time per week. 
5.2.4 Current participation in any other research protocol involving investigational 
drugs or therapies. 
5.2.5 Current cigarette smoking. 
5.2.6 Pregnancy, nursing mothers, and men or women of reproductive ability 
who are unwilling to use effective contraception for the duration of the 
active portion of the study. Women of childbearing potential must have a 
negative pregnancy test within two weeks prior to entry. 
5.2.7 Inability to understand the nature of the study or give informed consent. 
6.0 STUDY AGENTS 
6.1 Description of the tgAAVCF vector 
The tgAAVCF vector is an adeno-associated virus (AAV) based-vector containing the 
complete coding region of the CFTR gene. All viral genes have been removed from this 
vector. Transduction of cells with this vector results in expression of physiologically active 
CFTR protein. The tgAAVCF vector is supplied as a frozen, sterile formulation that is 
stored at temperatures below -60’C prior to use. The vector formulation is thawed at 37°C 
and diluted as appropriate immediately prior to instillation. The tgAAVCF vector is 
produced by Targeted Genetics Corporation (Seattle, Washington). 
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