A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002097
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1994

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002097 on ClinicalTrials.gov Archive Site
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A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.
A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and clinical pharmacology of intravenous nystatin.

Cohorts of three patients each are treated at escalating doses of intravenous nystatin, administered every other day, until the MTD is reached. Each cohort is observed for toxicity for at least 2 weeks before escalation in subsequent patient cohorts is initiated.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
Drug: Nystatin
Not Provided
Rios A, Brewton G, Crofoot G, Quesada J, Lenk R, Lopez-Berenstein G. A phase I-II clinical study of Nystatin-LF IV in patients with HIV infections. Int Conf AIDS. 1993 Jun 6-11;9(1):483 (abstract no PO-B26-2089)

*   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

Concurrent Medication:

Required:

  • Aerosolized pentamidine (300 mg once a month) for PCP prophylaxis in patients with CD4 count <= 200 cells/mm3. (Patients with CD4 count > 200 cells/mm3 who are already on aerosolized pentamidine may continue such therapy at the discretion of the investigator.)

Allowed:

  • Prophylaxis against Mycobacterium avium Complex in patients with CD4 count <= 100 cells/mm3.

Concurrent Treatment:

Allowed:

  • Local treatment for Kaposi's sarcoma lesions with less than 25 percent increase in measurable disease.

Patients must have:

  • HIV antibody positivity.
  • Absolute CD4 count < 500 cells/mm3 on two determinations within 15 days prior to study entry.
  • At least 6 months of prior zidovudine (AZT) therapy.
  • No active opportunistic infection requiring ongoing therapy.
  • Normal neurologic status by standard assessment.
  • Life expectancy of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Neoplasm other than basal cell carcinoma of the skin or stable untreated HIV-related Kaposi's sarcoma (provided there is no progression in the Kaposi's sarcoma beyond 25 percent of measurable disease).
  • Clinically significant cardiac disease.
  • Known hypersensitivity to polyene antibiotics.

Patients with the following prior conditions are excluded:

  • History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

  • Antiretroviral agents or interferons.
  • Biological response modifiers.
  • Corticosteroids.
  • Cytotoxic chemotherapeutic agents.
  • Drugs that can cause neutropenia or significant nephrotoxicity.
  • Rifampin or rifampin derivatives.
  • Systemic anti-infectives.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

  • Radiation therapy. Active drug or alcohol abuse.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002097
103B, AR-91-35,606-004
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Argus Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
April 1994

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