Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome

Completed · Not applicable

Conditions studied: HIV Infections, Histoplasmosis

In brief

To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.

Key facts

Study ID

NCT00000627

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

90

Expected to finish

1994-11-01

Last updated by the study team

2021-11-02

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Corticosteroids for up to 21 days at doses no greater than 20 mg/day prednisone (higher doses may be given for shorter durations, if clinically indicated).
• Zidovudine, oral contraceptives, methadone, narcotics, acyclovir, acetaminophen, sulfonamides, trimethoprim/sulfamethoxazole, pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis, topical antifungals, pyrimethamine, ganciclovir.
• Didanosine (ddI), dideoxycytidine (ddC), foscarnet, or other investigational drugs considered to be essential for patient management.
• Concurrent Treatment:
• Allowed:
• Transfusion.
• Patients must have the following:
• HIV infection.
• Histoplasmosis.
• Appropriate consent must be obtained from a parent or legal guardian for patients less than 18 years of age.
• Allowed:
• Hematologic and/or renal laboratory abnormalities.
• Concurrent malignancies.
• Concurrent infection with Mycobacteria.
• Patients with severe manifestations of histoplasmosis who are thought to be at risk of dying within one week should receive up to 250 mg amphotericin B for up to seven days prior to enrollment and then be re-evaluated. Patients who are still severely ill and do not meet eligibility criteria may not enter the study.
• Specific criteria defining life-threatening histoplasmosis include:
• Systolic blood pressure < 90 mm Hg without other cause; arterial pO2 < 60 torr without other cause; and SGOT > 10 x upper limit of normal or bilirubin > 3 x upper limit of normal. Any other cases not meeting this definition must be reviewed with the protocol chair.
• Prior Medication:
• Allowed:
• Amphotericin B (up to 250 mg) over 7 days in patients with severe histoplasmosis.
• Risk Behavior:
• Allowed:
• Patients with a history of high-risk behavior for HIV infection (bisexual or homosexual men, intravenous drug abusers, recipients of blood or blood products prior to May 1985, or sexual partners of any of the foregoing).

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Allergy to, or intolerance of, imidazoles or azoles.
• Active hepatitis (viral, drug induced, or other).
• Fungal infections for which the study drug is not indicated (e.g., aspergillosis, mucormycosis).
• CNS/CSF culture positive for pathogens other than H. capsulatum. If C. neoformans is subsequently identified and the patient is improving, the patient may be allowed to remain on study with the permission of the protocol chair.
• Concurrent Medication:
• Excluded:
• Corticosteroid use for > 21 days at > 20 mg/day of prednisone.
• Systemic antifungals.
• Prior Medication:
• Excluded:
• Amphotericin B at > 2.5 mg/kg for the current episode of histoplasmosis within 7 days prior to enrollment.
• Suppressive treatment for histoplasmosis or other fungal infections with > 200 mg/day of ketoconazole, fluconazole, or itraconazole, or more than 50 mg amphotericin B twice weekly.
• Risk Behavior:
• Excluded:
• Patients who the investigator feels would be undependable with regard to adherence to the protocol.
• Patients may not have the following prior conditions:
• History of allergy to, or intolerance of, imidazoles or azoles.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial — Worcester, Massachusetts, United States
• Univ of Missouri at Kansas City School of Medicine — Kansas City, Missouri, United States
• Infectious Diseases Association / Research Med Ctr — Kansas City, Missouri, United States
• St Louis Regional Hosp / St Louis Regional Med Ctr — St Louis, Missouri, United States
• Beth Israel Med Ctr — New York, New York, United States
• Cornell Univ Med Ctr — New York, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Montefiore Drug Treatment Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
• Montefiore Family Health Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
• Samaritan Village Inc / Bronx Municipal Hosp — The Bronx, New York, United States
• Montefiore Med Ctr / Bronx Municipal Hosp — The Bronx, New York, United States
• North Central Bronx Hosp / Bronx Municipal Hosp — The Bronx, New York, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Houston Veterans Administration Med Ctr — Houston, Texas, United States
• Univ TX Health Science Ctr — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.