Investigator may discontinue my participation in the Study at any time for any 
reason that the Investigator considers appropriate. 
C. Medication Restrictions . While I am in the Study, I should not take any other 
medications without the approval of the Investigator. Specifically, I should not 
use any anti-retroviral drugs like AZT, ddl or ddC within 45 days prior to or 
during treatment or in the first two weeks of observation following the last 
treatment because use of these drugs would make the treatment ineffective. If I 
use any of these drugs thereafter, I have to inform the Investigator. 
D. Study Plan . 
1 . If eligible for the Study, I will receive three courses of treatment consisting 
of injections into both arms and buttocks. The injections will be spaced at 
one month intervals. The injected material will be either HIV-IT (V) or a 
"placebo." The placebo will be an inactive substance. The "inactive 
substance" is the solution in which the HTV-IT (V) is normally suspended. 
I will be observed for two hours after each injection to identify any possible 
immediate side effects. If I receive a placebo, I will get a chance later to 
receive the gene therapy if the experimental treatment still appears to be safe 
at that time, and if I have not developed any AIDS defining conditions. 
2. Neither I nor my physician will know whether I am receiving the active 
treatment or a placebo. However, this information is available if it should 
be necessary in an emergency. 
3 . I will have a medical examination and blood drawn four days before each 
injection day, and periodically thereafter. Additional blood and urine tests 
will be done 70 days, 6 Months and 12 Months after the first injection. 
4. I will be asked to participate in follow-up for at least 3 years to identify 
long-term effects of the Treatment and to assess any effects on my immune 
system and medical condition. I will be examined and have blood and urine 
tests every six months during the second and subsequent years. 
Recombinant DNA Research, Volume 17 
[917] 
