Rios A, Brewton G, Crofoot G, Quesada J, Lenk R, Lopez-Berenstein G; International Conference on AIDS.

Int Conf AIDS. 1993 Jun 6-11; 9: 483 (abstract no. PO-B26-2089).

Twelve Oaks Hospital, Houston, Texas.

OBJECTIVES: To evaluate the clinical toxicity, safety and maximum tolerated dose (MTD) of Nystatin-LF IV administered to patients with HIV infection. METHODS: Twelve male patients have been treated with multiple escalating doses of Nystatin-LF administered at a rate of 2 mg. of Nystatin per minute every other day for a period of 12 weeks. The dose levels so far studies are 0.5 mg./kg. (two patients), 1 mg/kg (three patients), 2.0 mg./kg., (three patients) and 3.0 mg./kg. (two patients). RESULTS: Two patients at the 0.5 mg./kg. completed the twelve weeks of study and are currently on an extended maintenance protocol. Of the three patients registered at the 1 mg./kg. dose, one patient was terminated due to the development of infectious mononucleosis and another was terminated due to evidence of progression of disease as measured by changes in surrogate markers of HIV infection. The other patient completed the 12 weeks of study and is currently on an extended maintenance program. Of the patients at 2 mg./kg. dose, one patient was found to be unable to comply with the study after one week of treatment had been given. At the doses of 2 mg./kg. and 3 mg./kg., two patients at each level have completed 4 weeks of treatment and are on study. CONCLUSION: No major renal, neurological, pulmonary, or cardiac toxicity has been observed so far at any of the levels administered that could be directly attributed to Nystatin-LF IV. Of the 12 patients studied so far, only one patient has been terminated due to progression of disease and another due to the development of an infectious mononucleosis which could not be directly attributed to progression of his HIV infection (the patient had been exposed to a subject acutely infected with infectious mononucleosis). An analysis of surrogate markers is being conducted in those patients who have completed the 12 weeks of study and continue to be on extended maintenance program as well as for those who are about to complete the initial period of treatment. An MTD dose of Nystatin-LF has not been reached yet and the study is still open for patient recruitment.

Publication Types:

• Meeting Abstracts

Keywords:

• Clinical Trials, Phase I as Topic
• Disease Progression
• HIV Infections
• Humans
• Male
• Maximum Tolerated Dose
• Nystatin
• psychology

Other ID:

• 93335697

UI: 102205075

From Meeting Abstracts