VIAGENE HIV-I-02-1292 
PROTOCOL VERSION 1.4 
IND BB 
Title: 
A Double Blind, Controlled, Dose Escalating Phase I Clinical Trial to Evaluate the Safety and 
Biological Activity of HIV-IT (V) (HIV-Itttr env- Vector) in Asymptomatic HIV-1 Infected 
Subjects. 
4.1 Objectives 
4.1.1 In a Controlled, Dose Escalating, Phase I Study of Asymptomatic 
HIV-1 Infected Subjects to Determine: 
4. 1. 1 . 1 The safety and tolerability of administering three monthly doses of HIV- 
IT (V) at each of two different dose levels, and 
4. 1 . 1 .2 The pharmacokinetics of the neomycin resistance (neo 1 ) marker gene in 
successive blood samples. 
4.1.2 Secondary Objectives: In these Same Subjects, to Collect 
Preliminary Data On: 
4. 1 .2. 1 The pharmacodynamics of the cytotoxic T lymphocyte (CTL) response 
both in vitro and in vivo. 
4. 1.2.2 The pharmacodynamics of anti-HIV- Itttr specific gpl20 and p24 
antibodies. 
4 . 1 . 2 . 3 Measurable effects on viral load. 
4. 1.2.4 Measurable effects on T-cell subpopulations and other selected surrogate 
markers. 
4. 1.2.5 Measurable preliminary indications of possible effects on disease 
progress. 
Recombinant DNA Research, Volume 17 
[895] 
