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

A

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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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