AEGiS-CATIE: IMMUNOMODULATORS: Thalidomide for Ulcers Canadian AIDS Treatment Information Exchange
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IMMUNOMODULATORS: Thalidomide for Ulcers

TreatmentUpdate59 - Vol 7, No. 5 (May 1995)
Sean Hosein


* BACKGROUND

Some patients with HIV infection develop painful sores and ulcers on the skin, in the mouth and throat, intestines and other parts of the body. In some cases these ulcers may be caused by viruses such as CMV (cytomegalovirus) and HSV (herpes simplex virus). Bacteria and fungi can also cause ulcers. In cases where technicians have found microbes causing the ulcer, treatment with drugs--antibiotics, antifungals or antivirals--can bring some relief. There are cases where the ulcers do not appear to be caused by microbes. In such cases the ulcers may be caused by the immune system attacking parts of the body. Drugs that can 'suppress' the activity of the immune system may provide benefit. Corticosteroids may be helpful and doctors in Australia have recently reported their experience with the tranquilizer thalidomide.

* STUDY DETAILS

Researchers reviewed hospital records on 20 HIV-infected subjects who had ulcers and who received thalidomide. All of these doctors had prescribed a variety of drugs for treating ulcers on their patients but none worked. All subjects were adult males and most (80%) had less than 200 CD4+ cells. Subjects received thalidomide 200 mg/day for 2 weeks taken at night. In some cases doctors increased the dose of thalidomide to 300 mg/day and in others the dose remained the same but they received thalidomide for 2 months.

* RESULTS

In 70% of cases the ulcers healed; in others, they became smaller and less painful. Subjects with ulcers in their rectum required prolonged treatment-more than 2 weeks. About 1/3 of subjects developed side effects:

- rash-5 subjects - nerve damage (peripheral neuropathy)--1 subject - "excessive [tiredness, low energy]"--1 subject

The rash cleared when subjects stopped taking the drug. Others continued using thalidomide despite rash. The nerve damage cleared when the affected subject stopped using thalidomide. About 1% of non-HIV-infected subjects given thalidomide may develop a rash. The subject who felt 'excessive [tiredness and low energy]' stopped using thalidomide (the doctors did not state how long it took him to recover). Giving subjects the drug at night or reducing the dose to 100 mg/day seemed to reduce drowsiness during the day.

* THALIDOMIDE AND THE IMMUNE SYSTEM

The doctors conducting the study noted that thalidomide did not reduce CD4+ cell counts. Examination of their data revealed that 9 subjects had decreased CD4+ cell counts while 5 had increased CD4+ cell counts. Unfortunately CD4+ cell counts alone do not reveal the complex state the immune system is in when infected with HIV. Information on the effect of thalidomide on the immune system appears in the section on toxicity later in this issue of TreatmentUpdate.

REFERENCES:

1. Paterson DL, Georghiou P, Allworth AM and Kemp R. Thalidomide as treatment of refractory aphthous ulceration related to Human Immunodeficiency Virus infection. Clinical Infectious Diseases 1995;20:250-254.


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