Sefety and Immunogenicity of HIV-1 Immunogen in HIV Seropositive Subjects at Srinagarind Hospital : the first cohort study in Thailand.

Abstract

Objectives : To assess the safety and immunogenicity of HIV-1 Immunogen in

HIV seropositive subjects.

Study Design : Randomized , double blind, adjuvant-controlled clinical trial.

Setting : Srinagarind  Hospital. Khonkaen University.

Methodology : The 40 weeks trial was conducted in 33 volunteers who were randomized to receive either HIV-1 Immunogen or IFA at a 2:1 ratio on Week 1, week 12, 24, and 36.

Results: The primary end point for the trial was changes in CD4+ cell counts with secondary parameters of changes in CD8+ cell counts,  percentages of the CD4+  and CD8+, the ratio of CD4+ to CD8+, body weight, plasma HIV-1 RNA, HIV-1 DTH skin test and Western blot. As regards sefety, there was no serious adverse event in both treatment groups.  The result also showed that HIV-infected subjects who received HIV-1 Immunogen had significant higher increase in CD4+ cell counts.  This increased in CD4+ cell was associated with increased HIV specific immunogenicity on Western blots and enhanced HIV-1 DTH skin test.  Although there was no significant difference in the body weight, but increased in body weight was slightly higher for the HIV-1 Immunogen group compared to the IFA group. The plasma HIV-1 RNA remained stable for both treatment groups over the course of the trial.

Conclusions : The results of this trial suggest that HIV-1 Immunogen is safe and significant

increased in CD4+cell counts and HIV specific immunity compared to the adjuvant control

group.  This preliminary study also suggests that this therapy may be important treatment

alternative in countries where access to antiviral drugs is limited.

Key words :   HIV-1 Immunogen , immunogenicity, body weight.