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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000992 |
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.
Condition | Intervention | Phase |
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HIV Infections Histoplasmosis |
Drug: Itraconazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Pilot Study to Determine the Feasibility of Itraconazole for Suppression of Relapse of Disseminated Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome |
Estimated Enrollment: | 30 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Concurrent Treatment:
Allowed:
Prior Medication:
Required:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following conditions are excluded:
Prior Medication:
Excluded within 30 days of study entry:
Prior Treatment:
Excluded:
Risk Behavior:
Excluded:
Inclusion criteria are:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Louisiana State Univ Med Ctr / Tulane Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, New York | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Holmes Hosp / Univ of Cincinnati Med Ctr | |
Cincinnati, Ohio, United States, 452670405 | |
United States, Pennsylvania | |
Univ of Pittsburgh Med School | |
Pittsburgh, Pennsylvania, United States | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | LJ Wheat |
Study ID Numbers: | ACTG 084 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000992 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Ketoconazole Histoplasmosis |
Drug Evaluation Antifungal Agents Acquired Immunodeficiency Syndrome |
Opportunistic Infections Sexually Transmitted Diseases, Viral Clotrimazole Miconazole Histoplasmosis Acquired Immunodeficiency Syndrome Tioconazole Ketoconazole Itraconazole |
Hydroxyitraconazole Immunologic Deficiency Syndromes Virus Diseases Mycoses HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Retroviridae Infections |
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 |