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Study 10 of 19 for search of: | "Cryptosporidiosis" |
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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00057486 |
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.
Condition | Intervention | Phase |
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HIV Infections Cryptosporidiosis |
Drug: IL-12 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 2 |
Study Start Date: | September 1997 |
Estimated Study Completion Date: | June 2002 |
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 ng/kg 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 ng/kg 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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Study ID Numbers: | 2R01AI41735-04A2, 5R01AI041735-05 |
Study First Received: | April 2, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00057486 |
Health Authority: | United States: Food and Drug Administration |
Chronic Diarrhea Interleukin 12 |
Protozoan Infections Sexually Transmitted Diseases, Viral Interleukin-12 Diarrhea Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Intestinal Diseases Paromomycin Immunologic Deficiency Syndromes |
Virus Diseases Cryptosporidiosis Digestive System Diseases HIV Infections Azithromycin Sexually Transmitted Diseases Parasitic Diseases Intestinal Diseases, Parasitic Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Immunologic Factors Antineoplastic Agents Coccidiosis Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic |
Infection Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Lentivirus Infections Protozoan Infections, Animal Parasitic Diseases, Animal Growth Inhibitors Angiogenesis Modulating Agents |