Abstract. Organic pentavalent antimonials are one of the mainstays of treatment for visceral leishmaniasis (VL). Few data are available on the toxicity and efficacy of these drugs at the dosing schedule recommended by the Centers for Disease Control and Prevention (CDC) (Atlanta, GA). We analyzed 25 VL episodes in human immunodeficiency virus (HIV)-infected patients who were treated with meglumine antimoniate (MA) at the CDC-recommended dose in southern Spain. Adverse effects were observed in 14 (56%) VL episodes. In 7 (28%), treatment with MA was permanently discontinued due to serious adverse effects that included acute pancreatitis, acute renal failure, and leukopenia. Three (12%) patients died during therapy due to severe acute pancreatitis attributable to MA. The dosing regimen of MA currently recommended for treating VL is associated with a high rate of serious side effects in HIV-1-infected patients.Visceral leishmaniasis (VL) caused by Leishmania infantum is endemic in countries bordering the Mediterranean basin. It has been increasingly recognized that it affects human immunodeficiency virus type-1 (HIV-1)-infected patients, not only in this endemic area 1 , but also in non-endemic western countries. 2,3 Organic pentavalent antimonials (Sb V ) are one of the first-line drugs recommended by the Word Health Organization (WHO) for treating VL in the Mediterranean area. 4 In 1982, WHO (unpublished data) advocated treatment with 20 mg of Sb V /kg of body weight, with a maximum dose of 850 mg/day. The Centers for Disease Control (CDC) (Atlanta, GA) recommended in 1992 to remove the upper limit dose. 5 Data that supported this recommendation stemmed from clinical trials with patients not infected with HIV. 5 It was reported that higher daily doses without an upper limit resulted in better responses. Side effects were regarded as reversible and rarely severe.Patients with VL coinfected with HIV have a poor response to Sb V therapy. 1 Microbiologic cure is observed in less than half the cases and relapses are frequent. [6][7][8][9] In this setting, toxic effects of Sb V have seldom been reported in previous studies. 6,10,11 However, the dose of Sb V used in these patients was limited to a maximum of 850 mg/day. 6-12 Therefore, we assume that a low dose was administered. Thus, few data are available on efficacy and safety of the currently recommended Sb V dosing schedule to treat VL in HIV-1-infected individuals. 1 We provide herein data on toxicity and efficacy of meglumine antimoniate (MA) at a dose of 20 mg/kg of body weight/day with no dose limit in HIV-1-infected patients with VL. PATIENTS AND METHODSPatients. Fifty-one episodes of VL were diagnosed in 46 HIV-1-infected patients attending 2 University Hospital Acquired Immunodeficiency Syndrome (AIDS) care units in Seville, Spain from October 1993 to December 1997. Based on the diagnosis of the responsible physician, 25 VL episodes (49%) were treated with MA following the dosing schedule recommended by CDC in 1992. 5 Twenty-four were initial episodes and 1 w...

The prevalence of osteopenia in HIV-infected patients is high. However, the mechanisms implicated in bone mass loss in HIV infection are unclear. Because of this, we analyzed serum free testosterone and vitamin D3 hydroxylated metabolites in HIV-infected patients, with and without antiretroviral treatment, and the relation between them and osteopenia. Seventy-four HIV-infected patients were selected because they had frozen sera available at a date close to a DEXA evaluation. Free testosterone, 25(OH)D3, and 1,25(OH)2D3 were determined in frozen serum. There were no differences in free testosterone, 25(OH)D3, and 1,25(OH)2D3 levels between patients with and without osteopenia. 25(OH)D3 levels in naive and HAART-treated patients were 26.2 (10.3-32.8) and 33.1 (20.6-46.8) ng/ml, respectively (p = 0.04). 1,25(OH)2D3 levels in naive and HAART treated patients were 60.3 (49.2-80.8) and 85.5 (68-111.6) pmol/liter (p = 0.01). Free testosterone levels in 9 naive men and in 50 HAART-treated men were 42.6 (24.1-67.3) and 69.2 (47.5-112.1) pmol/liter, respectively (p = 0.04). In conclusion, HIV-infected patients with and without osteopenia showed similar levels of vitamin D metabolites and free testosterone. However, antiretroviral drug-naive patients showed lower serum levels of vitamin D metabolites and free testosterone than HAART-treated patients.

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