Houston, Texas 77027

  • HIV Infections


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.


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.



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Houston, Texas 77027
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 12, 2021

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