Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001998
- Run by
- Argus Pharmaceuticals
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Twelve Oaks Hosp — Houston, Texas, United States
Full record on ClinicalTrials.gov
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