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...
Date First Received: November 2, 1999
Last Updated: June 23, 2005
Verified by: NIH AIDS Clinical Trials Information Service, November 1992
Clinical Trial Phase: N/A | Start Date:
Overall Status: Completed
Brief Summary
Official Title: “Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Dose Comparison, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: Nystatin
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Argus Pharmaceuticals
Related Publications
References
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)
Additional Information
Information obtained from ClinicalTrials.gov on November 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00001998
Study ID Number: 103A
ClinicalTrials.gov Identifier: NCT00001998
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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