Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)
This study has been completed.
Sponsor:
Argus Pharmaceuticals
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001998
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1992
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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 | Intervention |
|---|---|
|
HIV Infections |
Drug: Nystatin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment |
| Official Title: | Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Nystatin
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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)
| ClinicalTrials.gov Identifier: | NCT00001998 History of Changes |
| Other Study ID Numbers: | 103A, AR-90-01-002 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Nystatin Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections AIDS-Related Complex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Nystatin Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Ionophores Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013