UCSD Project 93-418 
7/22/93 
CCTG 705 
Version 1.4 
H. Participation in the study requires that I use a barrier form of contraception (ie 
condom) This is to prevent 1) pregnancy in myself or my partner and 2) the 
possibility of transmitting the disabled virus in HIV-IT(V). 
I. If I am female and capable of child bearing, I will have a pregnancy test prior to 
beginning the study in order to ensure that I am not pregnant. During the study, 
I should make every effort to avoid pregnancy. If I miss a period or think I might 
be pregnant, I will notify the study doctor immediately. If I become pregnant, study 
therapy will be discontinued. If I become pregnant I may discuss with my doctor 
the option of continuing the pregnancy. 
J. No more than 145 ml (5 ounces) of blood will be drawn at any on visit. The total 
amount of blood that will be drawn is 430 ml (15 ounces) during the first 70 days 
of the study. 505 ml (18 ounces) will be drawn during months 3 to 12. 442 ml (15 
ounces) will be drawn during years 2 and 3. 
There is some risk in not taking my anti-HIV medication for the total of 18 days. The 
exact risk of this is unknown, although during this time the HIV in my body could 
increase. 
If I am injured as a result of participation in this research, treatment will be available. If 
I am eligible for veteran’s benefits, the cost of such treatment will be covered by the 
Veteran’s Administration. If not, the cost of such treatment may be covered by the 
Veteran’s Administration and the University of California, depending on a number of 
factor. The Veteran’s Administration and the University of California do not normally 
provide any other form of compensation for injury. For further information about this, I 
may call tha VA District Counsel at (619) 557-6718 or the Human Subject’s Committee 
Office at (619) 534-4520. 
There may be no direct benefit to me from this treatment. It is possible that my immune 
system may produce increased levels of CTL against HIV. Information from this study will 
help investigators learn more about the immune defenses to HIV and whether or not we 
can increase these defenses with HIV-IT (V). There is no known alternative to this 
therapy at this time, if my T-cell count is above 500, currently there is no indication for 
therapy. If my T-cell count is less than 500, 1 can receive standard therapy with AZT, ddl, 
ddC, or no therapy at all. 
Recombinant DNA Research, Volume 18 
[713] 
