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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Argus Pharmaceuticals
• Treatments: Nystatin

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.