Study of Itraconazole in Patients With Advanced HIV Infection

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002370
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Itraconazole

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 36
Detailed Description:

Patients will receive intravenous itraconazole solution twice daily for 2 days and then once daily for five additional days. Patients then randomized to receive twice-daily or once-daily itraconazole oral solution for an additional 28 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
  • Triazolam.
  • Terfenadine.
  • Astemizole.
  • Cisapride.
  • H2 blockers.
  • Omeprazole.
  • Continual antacids.
  • Didanosine.
  • Any medication known to affect absorption, metabolism or excretion of imidazole or azole compounds.

Patients with the following prior symptoms and conditions are excluded:

  • Previous hypersensitivity to azole antifungals.
  • History of surgical procedure that may interfere with absorption of itraconazole.
  • History of significant blood loss in the previous 30 days.

Prior Medication:

Excluded:

Excluded within 15 days prior to study entry:

  • Rifampin.
  • Rifabutin.
  • Phenobarbital.
  • Phenytoin.
  • Carbamazepine.
  • Digoxin.
  • Warfarin.
  • Midazolam.
  • Triazolam.

Excluded within 8 weeks prior to study entry:

  • Change in antiretroviral therapy.

Risk Behavior:

Excluded:

Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002370

Locations
United States, New York
Erie County Med Ctr / Pharmacy D
Buffalo, New York, United States, 14215
Sponsors and Collaborators
Janssen, LP
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002370     History of Changes
Other Study ID Numbers: 254B
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:
Itraconazole
Administration, Oral
Antifungal Agents
Acquired Immunodeficiency Syndrome
Drug Administration Schedule

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014