Trial of glucose versus fat emulsion in preparation of amphotericin for use in HIV infected patients with candidiasis.
OBJECTIVE
To compare the tolerance, efficacy, and pharmacokinetics of amphotericin deoxycholate (Fungizone) prepared in a parenteral fat emulsion (Intralipid 20%) or glucose in HIV patients with candidiasis.


METHODS
Non-blind randomised controlled trial.


METHODS
University hospital; tertiary clinical care.


METHODS
22 HIV positive patients with oral candidiasis.


METHODS
Amphotericin 1 mg/kg/day given on four consecutive days as a one hour infusion dissolved in either 5% glucose (amphotericin-glucose) or parenteral fat emulsion at a final concentration of 2 g/l fat emulsion (amphotericin-fat emulsion).


METHODS
Clinical tolerance (fever, chills, sweats, nausea, arterial pressure, and pulse rate); biological tolerance (serum creatinine, electrolyte, and magnesium values); clinical score of candidiasis; and serum concentrations of amphotericin.


RESULTS
11 patients were enrolled in each group. All the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment (n = 3) or severe chills (n = 2), or both. For patients completing the amphotericin-glucose treatment creatine concentration increased by 42 mumol/l; four of seven patients had at least one creatinine value > or = 133 mumol/l versus one of 11 receiving amphotericin-fat emulsion. Magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion. Clinical side effects were noted in 36/38 infusions with amphotericin-glucose but 10/44 with amphotericin-fat emulsion. Oral candidiasis score was reduced similarly in both groups. Serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose.


CONCLUSIONS
Clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion. Preparation is simple and cost effective. Its efficacy is similar to that of conventional amphotericin.
Chavanet
P Y
PY
Service des Maladies Infectieuses, Hopital du Bocage, Dijon, France.
Garry
I
I
Charlier
N
N
Caillot
D
D
Kisterman
J P
JP
D'Athis
M
M
Portier
H
H
D017088:AIDS-Related Opportunistic Infections / Q000150:complications / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002180:Candidiasis, Oral / Q000150:complications / Q000188:drug therapy*; D003840:Deoxycholic Acid / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004338:Drug Combinations; D005079:Excipients; D005217:Fat Emulsions, Intravenous; D005947:Glucose / Q000008:administration & dosage; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged
D000935:Antifungal Agents; D004338:Drug Combinations; D005079:Excipients; D005217:Fat Emulsions, Intravenous; D003840:Deoxycholic Acid; D000666:Amphotericin B; C059765:amphotericin B, deoxycholate drug combination; D005947:Glucose