NCT00002370

Brief Summary

To demonstrate a dosage regimen for intravenous itraconazole that produces a plasma concentration range comparable to that obtained after currently used oral dosages of itraconazole oral solution; and to obtain preliminary safety data in patients with advanced HIV disease.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

ItraconazoleAdministration, OralAntifungal AgentsAcquired Immunodeficiency SyndromeDrug Administration Schedule

Interventions

ItraconazoleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Antiretroviral therapy providing patient has already been on a stable, unchanged regimen for 8 weeks prior to study entry.
  • Patients must have:
  • Documented HIV infection.
  • CD4 lymphocyte count \< 300 cells/mm3.
  • No clinically significant abnormalities, elicited by history and physical examination.
  • No clinically significant abnormalities in blood count, biochemical profile, or urinalysis within 2 weeks of study entry.
  • Negative urine screening.
  • No clinically significant abnormalities of electrocardiogram.
  • Prior Medication:
  • Allowed:
  • Antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8 weeks prior to study entry.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Acute opportunistic infection or other significant concurrent illness that would preclude participation for the required 36 days.
  • Unable to swallow oral solution.
  • Obesity greater than 25% of ideal body weight.
  • Concurrent Medication:
  • Excluded:
  • Rifampin.
  • Rifabutin.
  • Phenobarbital.
  • Phenytoin.
  • Carbamazepine.
  • Digoxin.
  • Warfarin.
  • Midazolam.
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erie County Med Ctr / Pharmacy D

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-08

Locations

US(1)