Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Dose Comparison, Pharmacokinetics Study
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
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