AEGiS-11IAC: An evaluation of the safety and toxicities of thalidomide therapy in HIV-1 infected individuals.

11th International AIDS Conference


Vancouver, British Columbia — July 7-12, 1996

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An evaluation of the safety and toxicities of thalidomide therapy in HIV-1 infected individuals.

Int Conf AIDS 1996 Jul 7-12; 11:220 (abstract no. Th.B.170)
Haslett PA, Tramontana JM, Burroughs M, Hempstead M, Kaplan G; The Rockefeller University, New York, NY, USA.

OBJECTIVES: To evaluate the toxicities of thalidomide treatment in HIV-1 infected patients.

METHODS: Prospective study of the safety of thalidomide in adults with HIV-1 disease.

RESULTS: Thalidomide was administered to 42 patients at various stages of HIV-1 disease for a course of 21 to 28 days. The starting daily dose of thalidomide was 300mg in 10 patients, 200mg in 31 patients, and 50 mg in 1 patient. The most striking adverse reaction was the development of a drug rash and/or fever, observed in 15/42 (35.7%) of patients. Eleven of the 15 patients failed to complete the course of 21-28 days of therapy due to this idiosyncratic reaction (IR). The other 4 patients completed therapy, since the onset of IR was at the end of the course of treatment. Mean time to onset of IR was 10 days (range 3 - 17). Patients who developed IR had significantly lower CD4 lymphocyte counts (103+/- 35.2) than non-reactors (251+/-47.3, p=0.016). The incidence of IR was not dose related. A positive history of trimethoprim/sulfamethoxazole induced IR did not predict the development of a thalidomide reaction. Other reasons for failing to complete 21-28 days of thalidomide therapy were: oversedation, 2; mood changes, 1; symptoms of peripheral neuropathy, 2; HIV associated intercurrent illness, 2; loss to follow up, 1. Oversedation was dose related, occurring in 4/10 (40%) patients starting at 300mg, but only 1/31 (3.2%) of those starting at 200mg. Dose reduction resolved the oversedation in 3/5 patients. Biochemical or hematological abnormalities did not develop in any of the patients studied. Thus, in total, nineteen patients (45.2%) failed to complete a 21-28 day course of therapy.

CONCLUSIONS: Thalidomide, a specific inhibitor of tumour necrosis factor alpha, is emerging as a promising therapy for HIV associated aphthous ulcers and wasting. Dose limiting toxicities occurred in a significant minority of HIV-infected patients treated with thalidomide. This contrasts with the experience in HIV-negative patients, in whom this drug has been generally well tolerated. If the early promise of thalidomide as a useful agent in the management of HIV disease is borne out, it will be necessary to devise ways of minimizing or avoiding these reactions.

Keywords: AEGIS, HIV-1, Thalidomide, HIV Infections, CD4 Lymphocyte Count, Stomatitis, Aphthous, Anti-HIV Agents, Evaluation Studies, Tumor Necrosis Factor, Prospective Studies, Immunosuppressive Agents, Adult, Human, therapy, nursing, drug therapy, ICA11KWDaegis,hiv-1,thalidomide,hivinfections,cd4lymphocytecount,stomatitis,aphthous,anti-hivagents,evaluationstudies,tumornecrosisfactor,prospectivestudies,immunosuppressiveagents,adult,human,therapy,nursing,drugtherapy,ica11

960707
ThB170

Copyright © 1996 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.