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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Page 1 of 2 (8 locations)

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

A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDS | DecenTrialz