CryptosporidiosisNCT00001128
Treatment of Chronic Cryptosporidiosis in AIDS Patients
A study testing Interleukin-12, Paromomycin sulfate and Azithromycin in people with Cryptosporidiosis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptosporidiosis, HIV Infections
- What is being tested?
- Interleukin-12, Paromomycin sulfate and Azithromycin
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- 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 below 150 cells/mm3.
- Have been on stable anti-HIV therapy that includes at least 2 nucleoside analogues for at least 4 weeks.
- Have chronic diarrhea (3 bowel movements a day that are loose or watery, for 5 days per week over 3 weeks).
- Test positively for Cryptosporidium.
- Are at least 18 years old.
- Agree to use effective methods of birth control.
Who cannot join
- Patients will not be eligible for this study if they:
- Have any other active opportunistic (AIDS-related) infection.
- Require intravenous (IV) fluids.
- Have a history of an allergy to certain medications, such as colony-stimulating factors (G-CSF or GM-CSF) or a type of antibiotic.
- Are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Proof-of-Concept, Dose-Escalating Trial of Recombinant Human Interleukin-12 (rhIL-12) Versus Placebo Along With Paromomycin and Azithromycin for Chronic Cryptosporidiosis in AIDS
The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone.
Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.
Read the detailed description
Cryptosporidium parvum, an intracellular protozoan parasite, is a frequent cause of chronic diarrhea in HIV-infected patients, causing significant morbidity and mortality. Highly effective antiparasitic treatment for this infection is not currently available. Paromomycin and azithromycin have some efficacy and have been used in combination in a small number of patients. Immune reconstitution with highly active antiretroviral therapy appears to be the most effective therapy, but this is not possible for all patients. Interferon gamma expression is strongly associated with control of cryptosporidiosis, and IL-12 is the cytokine primarily responsible for stimulation of interferon gamma expression in vivo. It is hoped that treatment with recombinant human IL-12 can result in stimulation of an intestinal cytokine response in AIDS patients with cryptosporidiosis and that response combined with chemotherapy can lead to the elimination of detectable numbers of Cryptosporidium oocysts from the stools.
All patients receive azithromycin and paromomycin, and patients are randomized to add either IL-12 or placebo. IL-12 (or placebo) injections are given twice a week. Patients take their study medications for 4 weeks. During this time, they will be asked to record bowel movements and any symptoms they experience. Patients return to the clinic at least twice a week to receive IL-12 (or placebo) injections. At Weeks 2 and 4, patients are seen by one of the principal investigators. Blood samples are obtained for viral load measurements and CD4 count, as well as routine urinalysis. Patients undergo upper endoscopy with jejunal biopsy and colonoscopy with ileal biopsy between Weeks 2 and 4 of therapy for assays of intestinal cytokine expression. A final clinic visit occurs 12 weeks post-therapy for a physical exam and blood tests.
- Conditions
- Cryptosporidiosis, HIV Infections
- Being tested
- Interleukin-12, Paromomycin sulfate, Azithromycin
- Keywords
- AIDS-Related Opportunistic Infections, Cryptosporidiosis, Acquired Immunodeficiency Syndrome, Azithromycin, Paromomycin, Interleukin-12
- Medical subject headings
- Cryptosporidiosis, HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-12Drug
Paromomycin sulfateDrug
AzithromycinDrug
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)
- Primary completionJun 2005
- Study completionJun 2005
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Masking
- Double blind
- Enrolment
- 16 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Genetics Institute
- Investigators
- A. Clinton White, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001128
- Sponsor's protocol ID
- DAIDS R001
- Status last verified
- Jun 2003
- First submitted
- 17 Jan 2000
- Last updated
- 14 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Proof-of-Concept, Dose-Escalating Trial of Recombinant Human Interleukin-12 (rhIL-12) Versus Placebo Along With Paromomycin and Azithromycin for Chronic Cryptosporidiosis in AIDS
- ClinicalTrials.gov ID
- NCT00001128
- Acronym / sponsor ID
- DAIDS R001
- Conditions
- Cryptosporidiosis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Cryptosporidiosis, Acquired Immunodeficiency Syndrome, Azithromycin, Paromomycin, Interleukin-12
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Genetics Institute
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- 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 add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone.
Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.
Detailed description
Cryptosporidium parvum, an intracellular protozoan parasite, is a frequent cause of chronic diarrhea in HIV-infected patients, causing significant morbidity and mortality. Highly effective antiparasitic treatment for this infection is not currently available. Paromomycin and azithromycin have some efficacy and have been used in combination in a small number of patients. Immune reconstitution with highly active antiretroviral therapy appears to be the most effective therapy, but this is not possible for all patients. Interferon gamma expression is strongly associated with control of cryptosporidiosis, and IL-12 is the cytokine primarily responsible for stimulation of interferon gamma expression in vivo. It is hoped that treatment with recombinant human IL-12 can result in stimulation of an intestinal cytokine response in AIDS patients with cryptosporidiosis and that response combined with chemotherapy can lead to the elimination of detectable numbers of Cryptosporidium oocysts from the stools.
All patients receive azithromycin and paromomycin, and patients are randomized to add either IL-12 or placebo. IL-12 (or placebo) injections are given twice a week. Patients take their study medications for 4 weeks. During this time, they will be asked to record bowel movements and any symptoms they experience. Patients return to the clinic at least twice a week to receive IL-12 (or placebo) injections. At Weeks 2 and 4, patients are seen by one of the principal investigators. Blood samples are obtained for viral load measurements and CD4 count, as well as routine urinalysis. Patients undergo upper endoscopy with jejunal biopsy and colonoscopy with ileal biopsy between Weeks 2 and 4 of therapy for assays of intestinal cytokine expression. A final clinic visit occurs 12 weeks post-therapy for a physical exam and blood tests.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are HIV-positive.
- Have a CD4 cell count below 150 cells/mm3.
- Have been on stable anti-HIV therapy that includes at least 2 nucleoside analogues for at least 4 weeks.
- Have chronic diarrhea (3 bowel movements a day that are loose or watery, for 5 days per week over 3 weeks).
- Test positively for Cryptosporidium.
Key exclusion criteria (5 listed)
- Have any other active opportunistic (AIDS-related) infection.
- Require intravenous (IV) fluids.
- Have a history of an allergy to certain medications, such as colony-stimulating factors (G-CSF or GM-CSF) or a type of antibiotic.
- Are pregnant.
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 |
|---|---|---|
| Interleukin-12 | Drug | – |
| Paromomycin sulfate | Drug | – |
| Azithromycin | 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 14 Dec 2016.
Related trials for Cryptosporidiosis
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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.
A. Clinton White principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interleukin-12, Paromomycin sulfate and Azithromycin in people with Cryptosporidiosis and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 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: stopped early, as of the sponsor's last update on 14 Dec 2016. 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?
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 14 Dec 2016.