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Study of Itraconazole in Patients With Advanced HIV Infection

This study has been completed.

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    Clotrimazole    Miconazole    Miconazole nitrate    Tioconazole   

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


Study ID Numbers:   254B
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002370
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:
Virus Diseases
Sexually Transmitted Diseases, Viral
Clotrimazole
HIV Infections
Miconazole
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Tioconazole
Hydroxyitraconazole
Itraconazole
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
Antiparasitic Agents
Antiprotozoal Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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