treated in the 8th floor clinic of the Clinical Center or in the 1 1th floor day hospital. 
Each infusion will be administered over 1 hour and the patient will be observed for a 
total of 4 hours. As before, vital signs will be taken pre-infusion and every 15 minutes 
during the infusion, then hourly through 4 hours. Patients will return to the Clinical 
Center for outpatient evaluation daily for 4 days after each infusion, then weekly or less 
frequently (to be guided by the data produced) for the duration of active treatment, then 
monthly for 6 months of follow-up beyond the last lymphocyte infusion. 
Comprehensive safety and immunologic evaluations will be performed according to 
Section 8. 
6.3 Ancillary Therapy 
Licensed antiretroviral drugs, antiretrovial drugs available through an FDA approved 
expanded access program, and licensed drugs for HIV-related conditions are permitted 
on this protocol. Patients may continue to receive these medications, switch to different 
doses, and switch to different drugs throughout the course of the present study. Other 
experimental drugs are not permitted while on this study. All prescription and non- 
prescription concomitant medications will be recorded, listing generic name (unless a 
combination formulation), indication, dosage, route, and inclusive dates of 
administration. 
TESTS AND OBSERVATIONS 
7. 1 Screening 
Both donor and recipient will undergo the below screening tests. If more than 2 weeks 
elapse between screening and apheresis, the donor will be retested for HIV 
seronegativity. 
• Medical history (see Appendix C); 
• Complete disease characterization (see Appendix C); 
• Complete physical exam and Kamofsky Performance Status; 
• Chest x-ray and EKG; 
• Urine pregnancy test for females; 
• Laboratory tests (see also Appendix C). 
•• Hematology and coagulation tests; 
•• Blood chemistries and electrolytes; 
•• Urinalysis including microscopic; 
•• Blood samples for RCR testing. 
7.2 On-T reatment 
The following tests will be performed for the seropositive twin within each stage of the 
study at the indicated intervals: 
Treatment Period I 
• Complete physical examination (as before) day 1, and at week 5 post infusion; 
• Vital signs (pulse, respiration, supine blood pressure, oral temperature) at times 
0, 15, 30, 45, and 60 minutes during infusion, then hourly during the 4-hour 
observation period; 
• Oxygen saturation by continuous pulse oximetry throughout the infusion and 4- 
hour observation; 
Recombinant DNA Research, Volume 19 
