Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057486
Status:
TERMINATED
Last Update Posted:
2016-12-14
First Post:
2003-04-02
Brief Title:
Interleukin 12 IL-12 for the Treatment of Cryptosporidiosis in AIDS Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is no proven effective treatment for chronic diarrhea caused by the parasite Cryptosporidium in advanced AIDS This trial will test the safety of interleukin-12 IL-12 as part of a combination therapy for this parasite
Detailed Description:
Cryptosporidium parvum can cause chronic diarrhea and biliary disease in people with AIDS resulting in 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 However in clinical trials of this drug combination patients remained infected with the parasite despite improvement of their symptoms
Improving the immune system with highly active antiretroviral therapy HAART has been the most effective therapy described for cryptosporidiosis chronic infection with Cryptosporidium parvum with over 80 of patients showing improvement However immune reconstitution is not possible in all patients
Interferon gamma expression is strongly associated with control of cryptosporidiosis IL-12 stimulates interferon gamma and IL-12 treatment has been shown to prevent cryptosporidiosis in mice This study will evaluate IL-12 in combination with standard therapy for cryptosporidiosis in patients with AIDS
This is a dose-escalation study All patients will be treated with paromomycin and azithromycin The initial group will be treated with either 110 ngkg IL-12 6 patients or placebo injections 2 patients twice a week for 4 weeks If the initial dose is ineffective and the combination of drugs is tolerated a second group of patients will be randomized to either 300 ngkg IL-12 6 patients or placebo injections 2 patients twice a week for 4 weeks Patients will be evaluated for eradication of the parasite as measured by immunofluorescence and intestinal biopsy decreases in stool frequency decreases in 24 hour stool volume stimulation of intestinal Th1 cytokine production increases in body weight improvements in Karnofsky score and improvements in serum alkaline phosphatase levels and transaminases if elevated at baseline
Improving the immune system with highly active antiretroviral therapy HAART has been the most effective therapy described for cryptosporidiosis chronic infection with Cryptosporidium parvum with over 80 of patients showing improvement However immune reconstitution is not possible in all patients
Interferon gamma expression is strongly associated with control of cryptosporidiosis IL-12 stimulates interferon gamma and IL-12 treatment has been shown to prevent cryptosporidiosis in mice This study will evaluate IL-12 in combination with standard therapy for cryptosporidiosis in patients with AIDS
This is a dose-escalation study All patients will be treated with paromomycin and azithromycin The initial group will be treated with either 110 ngkg IL-12 6 patients or placebo injections 2 patients twice a week for 4 weeks If the initial dose is ineffective and the combination of drugs is tolerated a second group of patients will be randomized to either 300 ngkg IL-12 6 patients or placebo injections 2 patients twice a week for 4 weeks Patients will be evaluated for eradication of the parasite as measured by immunofluorescence and intestinal biopsy decreases in stool frequency decreases in 24 hour stool volume stimulation of intestinal Th1 cytokine production increases in body weight improvements in Karnofsky score and improvements in serum alkaline phosphatase levels and transaminases if elevated at baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AI041735-05 | NIH | None | httpsreporternihgovquickSearch5R01AI041735-05 |