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Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
This study has been completed.
Sponsored by: Argus Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00001998
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Nystatin

MedlinePlus related topics: AIDS
Drug Information available for: Nystatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Dose Comparison, Pharmacokinetics Study
Official Title: Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001998

Locations
United States, Texas
Twelve Oaks Hosp
Houston, Texas, United States, 77027
Sponsors and Collaborators
Argus Pharmaceuticals
  More Information

Publications:
Rios A, Crofoot GE, Lenk R, Hayman A, Rosenblum M, Lopez-Berestein G. A phase 1 single dose safety evaluation and pharmacokinetic (Pkc) study of nystatin-liposomal formulation nystatin-LF i.v. in patients with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):127 (abstract no PuB 7473)

Study ID Numbers: 103A, AR-90-01-002
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00001998  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Nystatin
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Clotrimazole
HIV Infections
Miconazole
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Tioconazole
Nystatin
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Infection
Pharmacologic Actions
Membrane Transport Modulators
Anti-Bacterial Agents
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses
Lentivirus Infections
Ionophores

ClinicalTrials.gov processed this record on January 15, 2009