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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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Nystatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002097

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

Publications:
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)

ClinicalTrials.gov Identifier: NCT00002097     History of Changes
Other Study ID Numbers: 103B, AR-91-35,606-004
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nystatin
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014