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

Sponsor

Argus Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00001998

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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.

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

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.