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



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

For Condition: HIV Infections
Status: Completed
Sponsor(s): Argus Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Twelve Oaks Hosp
Houston,  Texas,  77027
United States
 


Additional Information:
Study ID Numbers:  103A;  AR-90-01-002
Study Start Date: 
Record last reviewed: November 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001998

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