- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000992
A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDS
Pilot Study to Determine the Feasibility of Itraconazole for Suppression of Relapse of Disseminated Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
To test the effectiveness of itraconazole in preventing the recurrence of disseminated histoplasmosis in AIDS patients.
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Amphotericin B has been used to treat the infection. Although the response to this treatment is generally good, up to 90 percent of AIDS patients who have taken amphotericin B to treat their histoplasmosis infection will have a relapse (that is, they will get the disease again) within 12 months following treatment. Ketoconazole has been used to prevent relapse, but available information suggests that up to 50 percent of AIDS patients relapse even with ketoconazole treatment. A more effective therapy to prevent recurrence is needed. Itraconazole has been used successfully to treat disseminated histoplasmosis in non-AIDS patients and it is hoped that it may be more effective in preventing histoplasmosis relapse.
AIDS patients who have been successfully treated with amphotericin B for an acute first episode of disseminated histoplasmosis are selected for treatment. They receive daily oral doses of itraconazole for a total of 52 weeks. Patients who do not experience significant toxicity related to the drug may continue to receive itraconazole until the last patient completes 52 weeks of itraconazole therapy or has the study drug discontinued prior to completing 52 weeks of therapy. AMENDED: Patients will be treated for a minimum of 52 weeks. Patients who complete the 52 weeks and remain on the study drug will continue to be followed. If itraconazole becomes licensed for histoplasmosis, study drug must be discontinued at the end of 52 weeks of therapy or at the time of licensure for patients who have received more than 52 weeks of therapy.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- USC CRS
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University CRS
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
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Missouri
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Saint Louis, Missouri, United States
- Washington U CRS
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New York
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New York, New York, United States, 10021
- Cornell University A2201
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Ohio
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Cincinnati, Ohio, United States, 45267
- Univ. of Cincinnati CRS
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- Pitt CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Itraconazole therapy must begin no more than 6 weeks after discontinuing primary amphotericin B therapy; itraconazole therapy may begin immediately after stopping the primary therapy with amphotericin B.
Allowed:
- Oral contraceptives.
- Methadone.
- Narcotics.
- Acyclovir.
- Acetaminophen.
- Sulfonamides.
- Trimethoprim / sulfamethoxazole.
- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis (patients with a total CD4+ count < 200 or a history of PCP should receive PCP prophylaxis).
- Treatment IND drugs.
- Zidovudine.
- Topical antifungals.
- Discouraged:
- Antacids.
- Sucralfate.
- H2 blockers.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Prior Medication:
Required:
- Prior treatment with amphotericin B for disseminated histoplasmosis:
- minimum total dose of 15 mg/kg for patients < 67 kg, or 1 g for patients > 67 kg; must have been administered over 6 months or less.
Allowed:
- Amphotericin B as maintenance therapy for a maximum of 6 weeks following completion of primary therapy.
- Zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
- History of allergy to, or intolerance of, imidazoles or azoles.
- Clinical findings of active histoplasmosis.
- Histoplasmosis of the central nervous system.
- Inability to take oral medications reliably or severe malabsorption syndrome.
- Malignancies requiring cytotoxic therapy.
- Culture-proven systemic Mycobacterium tuberculosis, Mycobacterium avium-intracellulare, coccidioidomycosis, or cryptococcosis.
Concurrent Medication:
Excluded:
- Amphotericin B as maintenance therapy.
- Immunostimulants.
- Ketoconazole.
- Systemic antifungals.
- Steroids in excess of physiologic replacement doses.
- Cytotoxic chemotherapy.
- Investigational agents not specifically allowed.
- Antacids for 4 hours before and 4 hours after itraconazole.
Concurrent Treatment:
Excluded:
- Lymphocyte replacement.
Patients with the following conditions are excluded:
- History of allergy to, or intolerance of, imidazoles or azoles.
- Clinical findings of active histoplasmosis.
- Histoplasmosis of the central nervous system.
- Inability to take oral medications reliably or severe malabsorption syndrome.
- Malignancies requiring cytotoxic therapy.
- Culture-proven systemic Mycobacterium tuberculosis, Mycobacterium avium-intracellulare, coccidioidomycosis, or cryptococcosis.
Prior Medication:
Excluded within 30 days of study entry:
- Immunostimulants.
- Ketoconazole.
- Systemic antifungals.
- Steroids in excess of physiologic replacement doses.
- Cytotoxic chemotherapy.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
Risk Behavior:
Excluded:
- Patients who in the opinion of the investigator would be undependable with regard to adherence to protocol.
Inclusion criteria are:
- HIV infection documented by presence of antibody, by ELISA with Western blot confirmation, or serum p24 antigen, or by recovery of HIV in culture.
- Acute first episode of disseminated histoplasmosis documented by recovery and identification of H. capsulatum from cultures obtained from extrapulmonary sites.
- Oriented to person, place, and time, and able to give written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: LJ Wheat
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
- Histoplasmosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Itraconazole
Other Study ID Numbers
- ACTG 084
- 11059 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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