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

NCT00002097 | Completed Phase 1

• 2 other identifiers: 103BAR-91-35,606-004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Nystatin; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Nystatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Argus Pharmaceuticals: lead

Study Sites (1)

Twelve Oaks Hosp

Houston, Texas, 77027, United States

Location

Related Publications (1)

• 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)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Nystatin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1994-04

Locations

US (1)