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

Researchers enrolled 2 groups of HIV-infected subjects; in group A were 123 subjects (36 women and 87 men) with no symptoms of HIV-infection and an average CD4+ cell count of about 395 cells. Subjects were further divided into sub-groups A1 and A2.

In group B were subjects who had persistently swollen lymph nodes/glands and whose average CD4+ cell count was 265 cells. Subjects were once again divided into 2 sub-groups, B1 and B2.

Groups A1 and B1 received AZT 500 mg/day. Groups A2 and B2 received AZT 500 mg/day and TP1 according to the following dose and schedule: 70 mg/d injected into muscle for 7 days, then 70 mg/day 3 days weekly. Those subjects whose CD4+ cell counts fell below 200 cells could take antibiotics (aerosol pentamidine, Bactrim(R)/Septra(R) to prevent the life- threatening lung complication PCP. Subjects who developed bone marrow damage could reduce their dose of AZT. Data was reported for 12 months.

* RESULTS--GROUP A

- Infections

By the end of the study, 6 subjects receiving AZT alone had developed fungal infections in the mouth and/or throat, while 1 subject receiving AZT and TP1 developed the same infection. This difference between the 2 groups was statistically significant, that is, not likely due to chance alone. No subject developed AIDS.

- CD4+ cells

Subjects in group A2 (AZT and TP1) had increased CD4+ cell levels compared to:

+ their count at the start of the study (an increase of 8%) + subjects in group Al (an increase of 14%)

Moreover, subjects receiving AZT alone had a ''20C%o decrease in CD4+ cells" compared to their values at the start of the study.

- CMI

Subjects who received AZT and TP1 had a "25% increase in [CMI]", while those receiving AZT alone had an 18% decrease. This difference was statistically significant.

- Bone marrow

Subjects receiving AZT and TP1 had an 11% increase in levels of lymphocytes, while those on AZT alone had a Do decrease. As well, white blood cell counts increased by 15% in subjects receiving both drugs and fell by 28% in those in the AZT group. These differences were statistically significant.

- Dropouts/toxicity

Three subjects in the AZT only arm left the study because of stomach pain and nausea. In the combination arm, 3 subjects left because of allergic reactions (itching, swelling). The subjects receiving AZT only and 2 others receiving both drugs left the study because they could not tolerate the medications. The researchers did not release further details.

* RESULTS--GROUP B

- Infections

Fourteen subjects developed life-threatening infections while receiving AZT alone, and 9 subjects receiving both drugs developed AIDS. This difference was statistically significant. As well, subjects receiving the combination recovered 5 days faster than subjects receiving AZT alone. Twelve months into the study, the chance of not having AIDS was 15% in subjects on AZT alone and 40% in subjects on both study drugs.

- CD4+ cell counts

Subjects receiving AZT and TP1 had a 9% increase in their CD4+ cell counts compared to their levels at the start of the study, and a 14% increase compared to subjects receiving AZT alone. Subjects receiving AZT alone had a 25% decrease in their CD4+ cell count compared to their levels at the start of the study.

- CMI

Subjects receiving both study drugs had a 12% increase in CMI, while those on AZT alone showed a 33% decrease.

- Bone marrow

Subjects receiving AZT alone had decreases of 21% in their red blood cell counts (RBC) and 31% in their white blood cell counts (WBC), compared to values at the start of the study. In subjects receiving both study drugs, the equivalent changes were an 8% increase in the RBC and a 15% increase in the WBC.

- Dropouts/toxicity

Seven subjects receiving only AZT left the study because of the toxicity of that drug. Six subjects left the combination group because of allergic reactions and 4 others because they could not tolerate the study drugs.

In this study, thymostimulin appeared to delay the development of AIDS and protect the bone marrow from the toxic effects of AZT in some subjects. Thymostimulin is made by Serono, Italy, which is also testing human growth hormone to stop HIV-related weight loss and the drug Profasi(R) for treatment of HIV-related KS.

REFERENCES:

1. Barbaro G. Barbarrini G. De Rosa F. et al. Comparison of Zidovudine and Zidovudine-thymostimulin in the long term treatment of patients with asymptomatic human immunodeficiency virus infection and persistently generalized lymphadenopathy. Current Therapeutic Research 1995;56(4):369-384.

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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