CryptosporidiosisNCT00002278
A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS
A study testing Diclazuril in people with Cryptosporidiosis and HIV Infections, run by Janssen, LP at 3 sites in United States.
Trial summary
To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial related diarrhea in AIDS patients who have been treated in the double-blind study # JRD 64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with cryptosporidial related diarrhea and who meet the… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Cryptosporidiosis, HIV Infections
- What is being tested?
- Diclazuril
- How many people
- Not given
- Where
- 3 sitesUnited 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- Didanosine (ddI) allowed but discouraged, must have been stabilized on a constant dose for 3 weeks or more.
- Aerosolized pentamidine.
- Nystatin for control of oropharyngeal infections. Nystatin must not be taken within two hours of diclazuril.
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- Ganciclovir therapy only for CMV retinitis is permitted if the patient has been treated for at least 4 weeks prior to study entry and is stable on the drug.
- Loperamide may be taken if patient has been on long term loperamide prior to study entry but should not be started during the course of this protocol.
- Patients must have the following:
- Written informed consent given after the purpose and nature of the study, as well as the possible adverse effects related to the study drug, have been explained.
- Be willing and able to return for all subsequent weekly visits and the two week visit post completion of therapy (follow-up).
- Prior Medication:
- Allowed:
- Diclazuril.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Uncontrolled vomiting.
- Estimated survival less than 28 days.
- Other treatable enteric pathogens must be treated and eradicated prior to study entry.
- Concurrent Medication:
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- Excluded:
- Amphotericin B.
- Other antibiotics or antiprotozoal drugs.
- Other investigational agents.
- Trimethoprim/sulfamethoxazole.
- Antifungal medications except nystatin.
- Ganciclovir for other than Cytomegalovirus (CMV) retinitis.
- Antidiarrheal agents other than patients on long term loperamide prior to study entry.
- Patients with the following are excluded:
- Undependable in following the instructions of the investigator.
- Not able to swallow capsules.
- Uncontrolled vomiting.
- Estimated survival less than 28 days.
- Prior Medication:
- Excluded:
- Diclazuril within 2 weeks of study entry.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Cornell Univ Med Ctr
New York, New York, 10021
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
About this study
Official title: 28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial related diarrhea in AIDS patients who have been treated in the double-blind study # JRD 64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with cryptosporidial related diarrhea and who meet the inclusion and exclusion criteria of this protocol.
- Conditions
- Cryptosporidiosis, HIV Infections
- Being tested
- Diclazuril
- Keywords
- AIDS-Related Opportunistic Infections, Cryptosporidiosis, Diarrhea, diclazuril, Coccidiostats, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Cryptosporidiosis, HIV Infections, AIDS-Related Opportunistic Infections, Diarrhea, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclazurilDrug
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
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002278
- Sponsor's protocol ID
- 038B
- Other IDs
- JRD 64,433/1102
- Status last verified
- Jul 1990
- First submitted
- 2 Nov 1999
- 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
- 28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
- ClinicalTrials.gov ID
- NCT00002278
- Acronym / sponsor ID
- 038B
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Cryptosporidiosis, Diarrhea, diclazuril, Coccidiostats, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Janssen, LPIndustry (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.
To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial related diarrhea in AIDS patients who have been treated in the double-blind study # JRD 64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with cryptosporidial related diarrhea and who meet the inclusion and exclusion criteria of this protocol.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Zidovudine (AZT).
- Didanosine (ddI) allowed but discouraged, must have been stabilized on a constant dose for 3 weeks or more.
- Aerosolized pentamidine.
- Nystatin for control of oropharyngeal infections. Nystatin must not be taken within two hours of diclazuril.
- Ganciclovir therapy only for CMV retinitis is permitted if the patient has been treated for at least 4 weeks prior to study entry and is stable on the drug.
Key exclusion criteria (22 listed)
- Uncontrolled vomiting.
- Estimated survival less than 28 days.
- Other treatable enteric pathogens must be treated and eradicated prior to study entry.
- Amphotericin B.
- Other antibiotics or antiprotozoal drugs.
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 |
|---|---|---|
| Diclazuril | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclazuril in people with Cryptosporidiosis and HIV Infections, run by Janssen, LP at 3 sites 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 14 inclusion and 22 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: finished, 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 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.