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

Argus Pharmaceuticals

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Nystatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00001998

AR-90-01-002

103A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.