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Study of Itraconazole in Patients With Advanced HIV Infection
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Janssen, LP
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002370
  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

MedlinePlus related topics: AIDS
Drug Information available for: Itraconazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Dose Comparison, Pharmacokinetics Study
Official Title: Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection

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
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

Study ID Numbers: 254B
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002370     History of Changes
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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Itraconazole
Hydroxyitraconazole
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Antifungal Agents
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
Antiprotozoal Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Hydroxyitraconazole
Itraconazole
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Antiparasitic Agents
HIV Infections
Therapeutic Uses
Antifungal Agents
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009