CryptosporidiosisNCT00002158
A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis
A study testing Nitazoxanide in people with Cryptosporidiosis and HIV Infections, run by Romark Laboratories L.C. at 1 site in United States.
Trial summary
The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium). Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- Cryptosporidiosis, HIV Infections
- What is being tested?
- Nitazoxanide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are 3 to 65 years old (need consent of parent or guardian if under 18).
- Have AIDS.
- Have a CD4 count less than or equal to 200 cells/mm3. (Note: Patients with a CD4 count greater than 200 cells/mm3 but who have had cryptosporidiosis for at least 4 weeks may be eligible for this study.)
- Test positive for the parasite Cryptosporidium and have severe diarrhea (at least 4 bowel movements per day) for at least 2 weeks.
- Have received treatment for cryptosporidiosis but have become reinfected after treatment.
- Agree to practice abstinence or use effective methods of birth control (such as a condom) before and during the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Are pregnant.
- Are infected with certain other parasites.
- Have a history of certain intestinal diseases.
- Have received certain medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Compassionate Use of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).
Read the detailed description
Patients receive oral nitazoxanide daily for 14 days, after which those with complete clinical and parasitologic response discontinue treatment. Non-responders and partial responders may continue therapy for an additional 14 days at the discretion of the physician. Non-responders who show signs of improvement or who have partial response after 28 days and those who relapse following complete response may continue therapy for an additional month, up to 60 days total. [AS PER AMENDMENT 10/30/96: Patients receive a daily treatment for 4 weeks, with subsequent dose escalation in the absence of drug-related toxicity. Patients who exhibit complete response after 2 months may continue at a maintenance dose. Patients enrolled after October 15, 1996 are randomized to 1 of 2 doses, with subsequent escalations made in the absence of toxicity. Complete responders may continue therapy at a maintenance dose and duration determined by the investigator. Non-responders after 6 months of therapy have treatment discontinued.] [AS PER AMENDMENT 8/5/97: All patients are evaluated at Weeks 1, 2, 4, and monthly thereafter.] [AS PER AMENDMENT 8/17/99: New patients start therapy on a different dosage of nitazoxanide. Those who do not respond after 4 weeks of therapy will escalate to a higher dosage. Patients who show a complete response at 2 consecutive visits (2 weeks apart) discontinue nitazoxanide therapy and go to follow-up.] [AS PER AMENDMENT 2/3/00: The Week 1 clinical evaluation is deleted from the study procedures.]
- Conditions
- Cryptosporidiosis, HIV Infections
- Being tested
- Nitazoxanide
- Keywords
- Cryptosporidiosis, Diarrhea, Acquired Immunodeficiency Syndrome, nitazoxanide, Antiparasitic Agents
- Medical subject headings
- Cryptosporidiosis, HIV Infections, Diarrhea, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptosporidiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002158
- Sponsor's protocol ID
- 253B
- Other IDs
- UMD-95-009
- Status last verified
- Jul 2007
- First submitted
- 2 Nov 1999
- Last updated
- 10 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Compassionate Use of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
- ClinicalTrials.gov ID
- NCT00002158
- Acronym / sponsor ID
- 253B
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- Cryptosporidiosis, Diarrhea, Acquired Immunodeficiency Syndrome, nitazoxanide, Antiparasitic Agents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).
Detailed description
Patients receive oral nitazoxanide daily for 14 days, after which those with complete clinical and parasitologic response discontinue treatment. Non-responders and partial responders may continue therapy for an additional 14 days at the discretion of the physician. Non-responders who show signs of improvement or who have partial response after 28 days and those who relapse following complete response may continue therapy for an additional month, up to 60 days total. [AS PER AMENDMENT 10/30/96: Patients receive a daily treatment for 4 weeks, with subsequent dose escalation in the absence of drug-related toxicity. Patients who exhibit complete response after 2 months may continue at a maintenance dose. Patients enrolled after October 15, 1996 are randomized to 1 of 2 doses, with subsequent escalations made in the absence of toxicity. Complete responders may continue therapy at a maintenance dose and duration determined by the investigator. Non-responders after 6 months of therapy have treatment discontinued.] [AS PER AMENDMENT 8/5/97: All patients are evaluated at Weeks 1, 2, 4, and monthly thereafter.] [AS PER AMENDMENT 8/17/99: New patients start therapy on a different dosage of nitazoxanide. Those who do not respond after 4 weeks of therapy will escalate to a higher dosage. Patients who show a complete response at 2 consecutive visits (2 weeks apart) discontinue nitazoxanide therapy and go to follow-up.] [AS PER AMENDMENT 2/3/00: The Week 1 clinical evaluation is deleted from the study procedures.]
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Are 3 to 65 years old (need consent of parent or guardian if under 18).
- Have AIDS.
- Have a CD4 count less than or equal to 200 cells/mm3. (Note: Patients with a CD4 count greater than 200 cells/mm3 but who have had cryptosporidiosis for at least 4 weeks may be eligible for this study.)
- Test positive for the parasite Cryptosporidium and have severe diarrhea (at least 4 bowel movements per day) for at least 2 weeks.
- Have received treatment for cryptosporidiosis but have become reinfected after treatment.
Key exclusion criteria (5 listed)
- Are pregnant.
- Are infected with certain other parasites.
- Have a history of certain intestinal diseases.
- Have received certain medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitazoxanide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitazoxanide in people with Cryptosporidiosis and HIV Infections, run by Romark Laboratories L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2007.