4.8.2 Conditions Which May Necessitate Discontinuation of a Subject's 
Treatment 
4. 8 .2. 1 Treatment will be discontinued and a new replacement subject enrolled if 
a subject experiences an AIDS defining infection before follow-up Day 
70 of either treatment cycle; or 
4 . 8 . 2 . 2 If recurrent BRMP grade 3 or greater toxicity is encountered; or 
4. 8. 2. 3 If repeated CD4+ T-cell counts obtained at least 72 hours apart decline 
to an absolute level of <250. 
4. 8.2.4 If in the attending physician's judgment the subject's condition warrants 
initiation of anti-retroviral drug therapy prior to follow-up Day 70 of 
either cycle; or 
4. 8 .2. 5 If there are any willful protocol violations; or 
4. 8 .2. 6 If a subject develops another illness which requires treatment with a 
drug or agent (e.g., any immunosuppressive or chemotherapeutic agent) 
which is likely to interfere with the activity of the gene based 
immunostimulatory product investigated under this protocol; or 
4. 8. 2. 7 If the subject elects to withdraw from the study; or 
4. 8.2. 8 If, in the opinion of the attending physician, it is in the subject's best 
interest to withdraw from the study. 
4. 8 .2.9 Anyone receiving experimental treatment will be followed for up to three 
years. 
4.9 Termination of Study and Follow-Up Evaluation 
4.9.1 Product administration may be terminated at any time, at the subject's request. 
4.9.2 Subject participation may be terminated by the attending physician if justified by the 
subject's clinical status or if deemed in the subject's best interest. 
4.9.3 The protocol or any individual subject's study may be terminated or modified by 
written communication from the Viagene Study Coordinator. The investigator will 
be compensated for cases completed or in progress on a pro-rated basis. 
4.9.4 Commitment to the three-year follow-up evaluation schedule will be required of 
each subject who received any administration of HIV-IT (V). This follow-up data 
must be collected to properly evaluate safety. 
Recombinant DNA Research, Volume 17 
