Conclusions and results from ITV-1 clinical trial:

1. The application of the product ITV-1 shows good efficacy in patients with HIV-1 infection in its various stages – in 21 of them (68%) from the main group we note an increase in CD4 + T- lymphocytes; in 16 of them the increase is accompanied by an increase in the index CD4/CD8 and CD4%, which corresponds to a reduction in the immune activation. The increase in these parameters is statistically significant compared to the control group. The absolute number and the relative share of C08 + T lymphocytes is decreasing, too.

2. We observe a very good virological effect – the viral load in 80.5% of the patients is below the threshold of detection (however, we have no comparison to the control group).

3. The application of the product ITV-1 is well tolerated – only one patient manifested allergic dermal response. With regard to none of them we found variations in the hematological and biochemical parameters, neither did we establish clinically significant abnormal vital signs.

The Report was prepared by Assoc. Prof. Dr. Ivaylo Elenkov, MD, Chief researcher.

 

ITV-1 clinical trials final report (translated from Bulgarian): Final Report.pdf