Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have the following:
Positive HIV antibody test.
Diagnosis of AIDS-related complex (ARC).
CD4+ cell count between 100 and 300 cells/mm3.
Estimated life expectancy of at least 6 months.
Normal neurological status.
Patients with the following conditions or symptoms are excluded:
Active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush.
Patients with the following are excluded:
Active opportunistic infection.
Known hypersensitivity to polyene antibiotics.
Unwillingness to sign an informed consent or to be in compliance of protocol requirements.
Excluded within 72 hours of study entry:
Biologic response modifier agents.
Cytotoxic chemotherapeutic agents.
Potential neutropenic agents.
Rifampin or rifampin derivatives.
Phenytoin or barbiturates (inducers of microsomal enzymes).
All systemic medications.
Excluded within 72 hours prior to study entry:
Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.
Rios A, Crofoot GE, Lenk R, Hayman A, Rosenblum M, Lopez-Berestein G. A phase 1 single dose safety evaluation and pharmacokinetic (Pkc) study of nystatin-liposomal formulation nystatin-LF i.v. in patients with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):127 (abstract no PuB 7473)