TreatmentUpdate61; Volume 7, No. 7 - July 1995
Sean Hosein

Recognizing the defects in the immune system of HIV-infected people in the 1980s, researchers in Italy began the first of several trials of thymic hormones. For this study they enrolled 58 subjects who did not have AIDS, but had symptoms such as:

+ unintentional weight loss + night sweats + persistently swollen lymph glands/nodes + persistent lack of energy/tiredness

The researchers did not release data on the sex of subjects, although most were probably male; 43 were injection drug users, while most of the remaining subjects were men who had sex with men. Researchers did not provide CD4+ or CD8+ cell counts nor the precise proportion of lymphocytes that were CD4+ or CD8+ cells. Judging by the graphs, subjects entered the study with at least 300 CD4+ cells.

Subjects received either no drug or thymostimulin (TP1) 1 mg/kg of body weight per day for 14 days and then "1 mg/kg twice weekly for 6 months." Subjects were monitored for 12 months.

* RESULTS

Compared to subjects not receiving TP1, those who did receive it had increased or stable:

+ white blood cell counts + T and B cells

These changes between the 2 groups were statistically significant, that is, not likely due to chance alone. Among subjects not receiving TP1, CD4+ cell counts fell significantly by the 6th month of the study. No statistically significant changes occurred during the study between the two groups' CD4+ or CD8+ cells, red blood cells and platelets.

* SKIN TESTS

To find out the level of CMI (cell-mediated-immunity), nurses injected small amounts of protein from various microbes (bacteria, fungi and viruses) under the skin of subjects and watched for a reaction 48 hours later. Swelling and redness at the injection site indicated some level of CMI was present. For details about skin tests and measurement of CMI, please see TreatmentUpdate59.

At the start of the study, subjects assigned to receive no drug had "more positive reactions" than subjects assigned to receive TP1 . This difference was statistically significant. Twelve months later, subjects receiving TP1 had increased reactions to skin tests, while those reactions decreased in the other study group. This difference was statistically significant. The skin test kit used in this study was the 'Multitest' made by Pasteur-Merieux serum et vaccins.

* SYMPTOMS AND AIDS

Although there was a trend of decreasing symptoms in subjects who received TP1, this did not become statistically significant. Three subjects who did not receive TP1 developed AIDS, but this was not statistically significant. The researchers did not release findings about which infections subjects developed. Based on results from this study, the researchers began a larger study of TP1, the results of which are reported below.

REFERENCES:

1. Palmisano L, Chisesi T., Galli M, et al. Thymostimulin treatment for AIDS-related complex. Clinical Immunology and Immunopathology 1988;47:253-26 1.

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Copyright © 1995 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284  http://www.catie.ca