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

Sponsor

Argus Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002097

Collaborator

(none)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Nystatin	Phase 1

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.