CryptosporidiosisNCT00002027
Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
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 compared with placebo capsules as treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be based on the drug's clinical results and on its anti-protozoan effects. 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
- 60 participants
- 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:
- Patients who require anti-diarrheal medication must have received only one anti-diarrheal medication, loperamide, for at least 7 days prior to study entry. Dose of loperamide cannot be increased during study.
- Aerosolized pentamidine.
- Ganciclovir for cytomegalovirus (CMV) retinitis only but patient must be stable at least 4 weeks prior to study entry.
- Zidovudine (AZT).
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- Nystatin for oropharyngeal infections if not taken within 2 hours of diclazuril.
- Patients must have:
- Diagnosis of AIDS that is confirmed HIV positive by Western blot or AIDS defined diagnosis, or CDC defined AIDS. Stool specimens positive for cryptosporidium oocysts.
- Given written informed consent after the purpose and nature of the study, as well the possible drug-related adverse effects, have been explained.
- Ability to return for all subsequent applicable visits on days 8, 15, 21, and, if necessary, 28.
- Prior Medication:
- Allowed:
- Aerosolized pentamidine.
- Loperamide.
- Ganciclovir for cytomegalovirus (CMV) retinitis.
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks.
- Other treatable enteric pathogens including Clostridia must be treated and eradicated prior to study entry.
- Inability to swallow capsules.
- Uncontrolled vomiting.
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- Concurrent Medication:
- Excluded:
- Trimethoprim/sulfamethoxazole (Bactrim).
- Ganciclovir for any other reason except cytomegalovirus (CMV) retinitis.
- Other antibiotics.
- Other anti-protozoal drugs.
- Anti-fungal drugs other than nystatin.
- Amphotericin B.
- Other investigational drugs.
- Patients with the following are excluded:
- Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks.
- Inability to swallow capsules.
- Uncontrolled vomiting.
- Life expectancy of < 28 days.
- Can not be depended upon to follow the instructions of the investigator.
- Participation in an investigational study within 15 days of study entry.
- Prior Medication:
- Excluded within 15 days of study entry:
- Another investigational drug or device (except aerosolized pentamidine).
- Prior Treatment:
- Excluded within 15 days of study entry:
- Participation in an investigational study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dr Douglas Dieterich
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
To evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be based on the drug's clinical results and on its anti-protozoan effects. Safety will be assessed by the occurrence of side effects as reported by patients at their visits and by frequent monitoring of hematology, biochemistries, and urinalysis.
- 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002027
- Sponsor's protocol ID
- 038A
- Other IDs
- JRD 64,433/1101
- Status last verified
- Jun 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Connolly GM, Youle M, Gazzard BG. Diclazuril in the treatment of severe cryptosporidial diarrhoea in AIDS patients. AIDS. 1990 Jul;4(7):700-1. doi: 10.1097/00002030-199007000-00020. No abstract available.
PubMed 2397069Soave R, Dieterich D, Kotler D, Gassyuk E, Tierney AR, Liebes L, Legendre R. Oral diclazuril therapy for cryptosporidiosis. Int Conf AIDS. 1990 Jun 20-23;6(1):252 (abstract no ThB520)
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
- Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)
- ClinicalTrials.gov ID
- NCT00002027
- Acronym / sponsor ID
- 038A
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Cryptosporidiosis, Diarrhea, diclazuril, Coccidiostats, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- 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 compared with placebo capsules as treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be based on the drug's clinical results and on its anti-protozoan effects. Safety will be assessed by the occurrence of side effects as reported by patients at their visits and by frequent monitoring of hematology, biochemistries, and urinalysis.
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 (16 listed)
- Patients who require anti-diarrheal medication must have received only one anti-diarrheal medication, loperamide, for at least 7 days prior to study entry. Dose of loperamide cannot be increased during study.
- Aerosolized pentamidine.
- Ganciclovir for cytomegalovirus (CMV) retinitis only but patient must be stable at least 4 weeks prior to study entry.
- Zidovudine (AZT).
- Nystatin for oropharyngeal infections if not taken within 2 hours of diclazuril.
Key exclusion criteria (28 listed)
- Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks.
- Other treatable enteric pathogens including Clostridia must be treated and eradicated prior to study entry.
- Inability to swallow capsules.
- Uncontrolled vomiting.
- Trimethoprim/sulfamethoxazole (Bactrim).
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.
- Background: PubMed 2397069Connolly GM, Youle M, Gazzard BG. Diclazuril in the treatment of severe cryptosporidial diarrhoea in AIDS patients. AIDS. 1990 Jul;4(7):700-1. doi: 10.1097/00002030-199007000-00020. No abstract available.
- BackgroundSoave R, Dieterich D, Kotler D, Gassyuk E, Tierney AR, Liebes L, Legendre R. Oral diclazuril therapy for cryptosporidiosis. Int Conf AIDS. 1990 Jun 20-23;6(1):252 (abstract no ThB520)
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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 16 inclusion and 28 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?
On the ClinicalTrials.gov record for NCT00002027, which also lists 2 linked publications.
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.