A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in… (NCT00000975) | Clinical Trial Compass
CompletedPhase 2
A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients With AIDS
United States30 participants
Plain-language summary
To evaluate the feasibility of itraconazole as (1) primary therapy in histoplasmosis and (2) maintenance therapy after completion of primary therapy. To evaluate the effect of therapy of CNS histoplasmosis. To determine if resistance to drug occurs in patients who fail therapy.
Histoplasmosis is a serious opportunistic infection in patients with AIDS. Although the clinical response to amphotericin B treatment in the AIDS patients is generally good, administration difficulties and toxicity detract from its usefulness. Oral treatment with ketoconazole overcomes these limitations of amphotericin B, but does not appear to be effective for primary treatment in patients with AIDS. Itraconazole is a triazole compound in which preclinical studies have demonstrated activity against Histoplasmosis capsulatum. Preclinical studies have also shown that itraconazole appears effective in the treatment of histoplasmosis. The frequency of adverse reactions to itraconazole has been low in several studies. Central nervous system (CNS) involvement occurs in up to 20 percent of patients with histoplasmosis, and appears to have a poor response to amphotericin B treatment. Itraconazole has been used successfully in a small number of patients with cryptococcal meningitis, supporting a study of its use in CNS histoplasmosis.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Concurrent Medication:
Allowed:
* Vincristine, vinblastine, bleomycin, or interferon for Kaposi's sarcoma.
* Erythropoietin.
* Didanosine by exemption for 10 patients.
* Barbiturates.
* Coumarin-type anticoagulants.
* Oral contraceptives.
* Digoxin.
* Methadone.
* Narcotics.
* Acyclovir.
* Acetaminophen.
* Sulfonamides.
* Trimethoprim / sulfamethoxazole.
* Pentamidine for Pneumocystis carinii pneumonia (PCP) or PCP prophylaxis.
* Topical antifungals.
* Pyrimethamine.
* Ganciclovir.
* AZT.
* Stress doses of steroids in patients with adrenal insufficiency.
Concurrent Treatment:
Allowed:
* Dose reduction or interruption of myelosuppressive therapy and transfusion to maintain hemoglobin of 7 or more g/dl.
* Radiation therapy.
Patient must:
* Show laboratory evidence of HIV infection and disseminated histoplasmosis.
* Be oriented to person, place, and time.
* Be able to give written informed consent (appropriate consent must be obtained from a parent or legal guardian for patients under 18 years of age).
Allowed:
* Abnormal liver function tests in Grade 3 toxicity range if liver biopsy shows evidence that histoplasmosis caused these abnormalities.
* Mucocutaneous candidiasis.
Prior Medication:
Allowed:
* Amphotericin B or ketoconazole for pulmonary histoplasmosis at least 3 months prior to study entry.
* Azidothymidine (AZT).
* Vincristine, vinblastine, bleomycin, or interferon for mucocutaneous Kaposi's sarcoma.
* Prophylaxis for Pneumocystis carin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000975
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)