Status:
COMPLETED
A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Histoplasmosis
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
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. Amph...
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 perc...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 1992
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00000992
End Date
June 1 1992
Last Update
November 1 2021
Active Locations (8)
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1
USC CRS
Los Angeles, California, United States, 90033
2
Northwestern University CRS
Chicago, Illinois, United States, 60611
3
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
4
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States, 70112