A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Pat… (NCT00000771) | Clinical Trial Compass
CompletedPhase 2
A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3
United States, Puerto Rico68 participants
Plain-language summary
To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit.
In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
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:
* Antiretroviral therapy.
* Macrolides for disseminated Mycobacterium avium.
* Atovaquone for toxoplasmosis.
* Other antimicrobials for concurrent infections.
* Lomotil, Imodium, or deodorized opium tincture in a standardized regimen for diarrhea.
Patients must have:
* Advanced HIV disease.
* Diarrhea presumptively caused by Cryptosporidia.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Hypersensitivity to aminoglycosides.
* Inability to swallow capsules.
* Active infection due to other enteric pathogens. Previous diagnosis of CMV or MAC infection permitted if patient is currently stabilized on a therapeutic regimen (clarithromycin up to 500 mg bid or azithromycin up to 600 mg daily).
* Other known causes for diarrhea (e.g., malabsorption syndrome, gastrointestinal Kaposi's sarcoma).
Concurrent Medication:
Excluded during the first 9 weeks of study:
* Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum).
* Octreotide acetate (Sandostatin).
* Antidiarrheals other than those specifically allowed.
* Clarithromycin if initiated at 500 mg or higher or azithromycin if initiated at 600 mg or higher.
Prior Medication:
Excluded:
* Paromomycin at \> 1 g/day for \>= 14 days prior to study entry.
Excluded within 14 days prior to study entry:
* Agents with putative anticryptosporidial activity (such…
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 IDNCT00000771
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)