UCSD Project 93-418 
7/22/93 
CCTG 705 
Version 1.4 
SAN DIEGO VETERAN’S ADMINISTRATION MEDICAL CENTER 
CONSENT TO ACT AS A RESEARCH SUBJECT 
CCTG 705: AN OPEN-LABEL, PHASE I/ll CLINICAL TRIAL TO EVALUATE THE 
SAFETY AND BIOLOGICAL ACTIVITY OF HIV-IT (V) (HIV-1 lll B ENV/REV- 
RETROVIRAL VECTOR) IN HIV-1 INFECTED SUBJECTS. 
Drs. Richard Haubrich, J. Allen McCutchan, Diane Havlir, T.C. Meng, Susan Little, and 
their associates are conducting a study to see if immunization with HIV-IT (V) can improve 
my body’s ability to produce killer cells against HIV. Part of the normal immune response 
to HIV is to produce CTL (cytotoxic T lymphocytes) - which are cells that kill HIV. 
Preliminary studies in mice and monkeys have shown that HIV-IT (V) can stimulate CTL 
in these animals. The purpose of this study is to evaluate the safety of HIV-IT (V) and to 
see if it increases the level of CTL in my body. I have been asked to participate because 
I have HIV infection. 
If I agree to participate the following will happen: 
1 . I will be seen for a screening evaluation which includes: 
A. A medical history and physical exam. 
B. Blood tests, including a pregnancy test (if applicable) 
C. Skin testing. 
The skin tests are done by injecting, using a very small needle, standard skin test 
substances into my arm. I will return in two days to have this skin test read. In addition 
to standard laboratory tests I will have 120 ml of blood (about 1 /2 cup) drawn to evaluate 
CTL in my blood. If I qualify, then I will return to the clinic for injection of HIV-IT (V). I 
must stop my anti-HIV medication (i.e. AZT, ddl ,or ddC) three days before each injection 
and remain off therapy until three days after each injection. I will receive three monthly 
injections of HIV-IT (V) into a muscle in an arm, the buttocks, or both. After each 
injection, I will be observed in the clinic for two hours to look for side effects. 
Two weeks after each injection, I will return to the clinic for a safety evaluation which 
includes history, relevant physical exam and blood tests to monitor safety and to look for 
CTL. If I am female, a repeat pregnancy test will be run on days 14 and 42. 
I will return to the clinical at months 3, 4, 5, 6, 12, 18, 24, 30, and 36 and have similar 
evaluations to ensure safety and to look for the effect of the injections on my CTL’s. 
Recombinant DNA Research, Volume 18 
[711] 
