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


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Acquired Immune Deficiency Syndrome

Acquired Immunodeficiency Syndrome; AIDS; AIDS & HIV; AIDS - Neurological Complications; AIDS/HIV; HIV; HIV and AIDS; HIV/AIDS; HIV/AIDS & STDs; Human Immunodeficiency Virus; SIDA 




Clinical Trial: 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: AIDS Clinical Trials Information Service

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 Treatment or Intervention
HIV Infections
 Drug: Nystatin

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Dose Comparison, Pharmacokinetics Study

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:

Patients with the following are excluded:

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.


Location Information


Texas
      Twelve Oaks Hosp, Houston,  Texas,  77027,  United States

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
Record last reviewed:  November 1992
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001998
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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November 27, 2009



Page Updated: October 15, 2009
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