A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patien… (NCT00000992) | Clinical Trial Compass
CompletedPhase 1
A Study of Itraconazole in Preventing the Return of Histoplasmosis, a Fungal Infection, in Patients With AIDS
United States30 participants
Plain-language 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. 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.
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:
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 …
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 IDNCT00000992
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)