A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS
Pilot Study To Determine the Feasibility of Itraconazole for Primary Treatment and Suppression of Relapse of Disseminated Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
2 other identifiers
interventional
30
1 country
12
Brief Summary
To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
12 active sites
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
Study Completion
Last participant's last visit for all outcomes
September 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Vincristine, vinblastine, bleomycin, or interferon for Kaposi's sarcoma.
- Erythropoietin.
- Didanosine by exemption for 10 patients.
- Barbiturates.
- Coumarin-type anticoagulants.
- Oral contraceptives.
- Digoxin.
- Methadone.
- Narcotics.
- Acyclovir.
- Acetaminophen.
- Sulfonamides.
- Trimethoprim / sulfamethoxazole.
- +23 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Severely ill, or at risk of dying from histoplasmosis within the first week of treatment, as indicated by systolic blood pressure less than 90 mm Hg , or PO2 less than 60.
- Active CNS lesions, malignancies, or infections other than MAI.
- Severe malabsorption syndrome (persistent diarrhea more than 4 weeks duration with at least 4 loose stools per day accompanied by a 10 percent or greater weight loss).
- Requiring cytotoxic therapy for malignancies.
- Any systemic fungal infection other than histoplasmosis.
- Systemic Mycobacterium avium intracellulare.
- Receiving treatment for other acute opportunistic infections whose signs and symptoms have not yet resolved or stabilized.
- History of allergy to or intolerance of imidazoles or azoles.
- Concurrent Medication:
- Excluded:
- All other systemic antifungal agents.
- Investigational drugs not specifically allowed.
- Oral hypoglycemics.
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
USC CRS
Los Angeles, California, 90033, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, 70112, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
Washington U CRS
St Louis, Missouri, United States
Cornell University A2201
New York, New York, 10021, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Pitt CRS
Pittsburgh, Pennsylvania, United States
Related Publications (2)
Hecht FM, Wheat J, Korzun AH, Hafner R, Skahan KJ, Larsen R, Limjoco MT, Simpson M, Schneider D, Keefer MC, Clark R, Lai KK, Jacobson JM, Squires K, Bartlett JA, Powderly W. Itraconazole maintenance treatment for histoplasmosis in AIDS: a prospective, multicenter trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Oct 1;16(2):100-7. doi: 10.1097/00042560-199710010-00005.
PMID: 9358104BACKGROUNDWheat J, Hafner R, Korzun AH, Limjoco MT, Spencer P, Larsen RA, Hecht FM, Powderly W. Itraconazole treatment of disseminated histoplasmosis in patients with the acquired immunodeficiency syndrome. AIDS Clinical Trial Group. Am J Med. 1995 Apr;98(4):336-42. doi: 10.1016/s0002-9343(99)80311-8.
PMID: 7709945BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
LJ Wheat
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
September 1, 1994
Last Updated
November 4, 2021
Record last verified: 2021-10