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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Nystatin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Argus Pharmaceuticals

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Twelve Oaks Hosp, Houston, Texas 77027, United States
Additional Information

Related publications:

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)


Last updated: June 23, 2005

Page last updated: August 23, 2015

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