CryptosporidiosisPhase 3NCT00004986
Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
A Phase 3 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 it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Cryptosporidiosis, HIV Infections
- What is being tested?
- Nitazoxanide
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to not given
- Phase
- Phase 3
- 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 13 years and older
- 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 HIV-positive.
- Have a CD4 cell count of 50 cells/mm3 or less.
- Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry.
- Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment.
- Are able to take medications by mouth.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Agree to use an effective method of birth control (such as condoms) during the study.
Who cannot join
- Patients will not be eligible if they:
- Have certain diseases or infections of the intestines.
- Have ever taken nitazoxanide.
- Have taken certain experimental drugs within 14 days of enrollment.
- Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin.
- Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study.
- Are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States
The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
Read the detailed description
Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.
- Conditions
- Cryptosporidiosis, HIV Infections
- Being tested
- Nitazoxanide
- Keywords
- AIDS-Related Opportunistic Infections, Cryptosporidiosis, Drug Evaluation, Antiprotozoal Agents, Treatment Failure, nitazoxanide
- Medical subject headings
- Cryptosporidiosis, HIV Infections, AIDS-Related Opportunistic Infections
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)
- Study startFeb 2000
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 3
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004986
- Sponsor's protocol ID
- 253C
- Other IDs
- RM-NTZ-99-003
- Status last verified
- Aug 2000
- First submitted
- 16 Mar 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States
- ClinicalTrials.gov ID
- NCT00004986
- Acronym / sponsor ID
- 253C
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Cryptosporidiosis, Drug Evaluation, Antiprotozoal Agents, Treatment Failure, nitazoxanide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2000
- 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 it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
Detailed description
Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Are HIV-positive.
- Have a CD4 cell count of 50 cells/mm3 or less.
- Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry.
- Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment.
- Are able to take medications by mouth.
Key exclusion criteria (7 listed)
- Have certain diseases or infections of the intestines.
- Have ever taken nitazoxanide.
- Have taken certain experimental drugs within 14 days of enrollment.
- Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin.
- Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study.
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
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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 Phase 3 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Jun 2005. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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 24 Jun 2005.