HIV Infections
Conditions
Keywords
Nystatin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
Brief summary
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.
Interventions
DRUGNystatin
Sponsors
Argus Pharmaceuticals
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Co-existing Condition: 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. Prior Medication: Excluded within 72 hours of study entry: * Biologic response modifier agents. * Corticosteroids. * 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. Prior Treatment: 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.
Countries
United States
Outcome results
None listed