Acquired Immune Deficiency Syndrome |
Acquired Immunodeficiency Syndrome; AIDS; AIDS & HIV; AIDS - Neurological Complications; AIDS/HIV; HIV; HIV and AIDS; HIV/AIDS; HIV/AIDS & STDs; Human Immunodeficiency Virus; SIDA |
Clinical Trial: Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
This study has been completed.
|
Purpose
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.
| Condition | Treatment or Intervention |
|---|---|
| HIV Infections | Drug: Nystatin |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Dose Comparison, Pharmacokinetics Study
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: 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.
Location Information
Texas
Twelve Oaks Hosp, Houston, Texas, 77027, United States
More Information
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)
Record last reviewed: November 1992
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00001998
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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