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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001998
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1992

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00001998 on ClinicalTrials.gov Archive Site
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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.

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Interventional
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Endpoint Classification: Pharmacokinetics Study
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.

Both
18 Years and older
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