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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Nystatin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Twelve Oaks Hosp

Houston, Texas, United States

Site Status

Countries

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United States

References

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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)

Reference Type BACKGROUND

Other Identifiers

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AR-90-01-002

Identifier Type: -

Identifier Source: secondary_id

103A