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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001998
• Other study ID #: 103A
• Secondary ID: AR-90-01-002
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1992
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Prior Medication:

Excluded within 72 hours of study entry:

• Biologic response modifier agents.

• Corticosteroids.

• Cytotoxic chemotherapeutic agents.

• Potential nephrotoxins.

• Potential neutropenic agents.

• Rifampin or rifampin derivatives.

• Systemic anti-infectives.

• Phenytoin or barbiturates (inducers of microsomal enzymes).

• All systemic medications.

Prior Treatment:

Excluded within 72 hours prior to study entry:

• Radiation therapy.

Active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS-Related Complex
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Nystatin

Locations

Country	Name	City	State
United States	Twelve Oaks Hosp	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Argus Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rios A, Crofoot GE, Lenk R, Hayman A, Rosenblum M, Lopez-Berestein G. A phase 1 single dose safety evaluation and pharmacokinetic (Pkc) study of nystatin-liposomal formulation nystatin-LF i.v. in patients with HIV infection. Int Conf AIDS. 1992 Jul 19-24;8(3):127 (abstract no PuB 7473)