TreatmentUpdate80 - Vol. 8, No. 0; August 1997
Sean Hosein

Thalidomide is known to cause birth defects and nerve damage. In non-HIV-infected people the drug appears to be "well tolerated." In the early 1990s, when more PHAs began to use thalidomide, doctors noticed that it was not as "well tolerated" as it had been when the drug was first used in the early 1960s. Researchers in the US who conducted 3 studies of thalidomide in PHAs report that the toxicity of this drug generally increases as CD4+ cell counts fall below the 200 cell mark.

Study details

Over 3 years, the researchers conducted 3 studies each lasting for between 2 to 3 weeks. Fifty-six volunteers (3 female, 53 male) entered the study, half of whom had a CD4+ cell count of 154 cells. The dose of thalidomide used varied between 200 and 300 mg/night.

Toxicity

As reported in another short term study, CD4+ cell counts did not change before and after use of thalidomide. Over 40% of subjects could not complete the study using the dose of thalidomide with which they started because of toxicity, most commonly, "rash and/or fever." Rash tended to occur on the hands/feet and parts of the limbs closest to them as well as on the trunk of the body. Subjects who experienced rash/fever were likely to have lower CD4+ counts (53 cells) than subjects who did not (242 cells) have these side effects. Although drowsiness was experienced by all subjects, it was most severe in those receiving the 300 mg dose. Other less common side effects included constipation (5 subjects) and depressed mood (2 subjects). Two subjects reported pain in the hands/feet. All of these side effects cleared once subjects stopped using thalidomide. As an experiment, 4 subjects who experienced rash/fever on thalidomide were once more given the drug but they all rapidly developed side effects.

The doctors who conducted the 3 studies suggest that HIV infection makes people more sensitive to the toxicity of thalidomide. In a separate experiment doctors gave 10 subjects gradually increasing doses of thalidomide and found that PHAs were able to tolerate the drug for up to 1 year without serious toxicity. No details about the effect of thalidomide on viral load or the immune system were released.

REFERENCE:

1. Haslett P, Tramontana J, Buroughs M, et al. Adverse reactions to thalidomide in patients infected with Human Immunodeficiency Virus. Clinical Infectious Diseases 1997;24:1223-1227.

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