Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)

Launched by ARGUS PHARMACEUTICALS · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • 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.