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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001998
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
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.
Not Provided
Interventional
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Primary Purpose: Treatment
HIV Infections
Drug: Nystatin
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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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00001998
103A
AR-90-01-002
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Argus Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
November 1992

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP