To define the pharmacokinetic characteristics of Nystatin LF IV (intravenous) in human
subjects with AIDS-related complex (ARC) after administration of a single IV dose at each of
4 dose levels.
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
Excluded within 72 hours of study entry:
- Biologic response modifier agents.
- Cytotoxic chemotherapeutic agents.
- Potential nephrotoxins.
- Potential neutropenic agents.
- Rifampin or rifampin derivatives.
- Systemic anti-infectives.
- Phenytoin or barbiturates (inducers of microsomal enzymes).
- All systemic medications.
Excluded within 72 hours prior to study entry:
- Radiation therapy.
Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks
prior to start of study.