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Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients Clinical research trials and Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients. Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients  Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
For Condition: HIV Infections,Cryptosporidiosis
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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).
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - HIV infection - CD4 cell count < 150 cells/µl - Stable antiretroviral regime that includes at least two nucleotide analogues for at least 4 weeks - Viral load < 10,000 copies/ml - Chronic diarrhea, defined as three loose or watery bowel movements a day for 5 days per week over 3 weeks - Stool positive for Cryptosporidium and no other enteric pathogen (bacterial culture, C. difficile toxin assay, AFB stain, ova and parasite examination, and stain for microsporidia) - Karnofsky score >= 70 - Acceptable methods of contraception Exclusion Criteria: - Pregnant - Active opportunistic infection - History of hypersensitivity or significant intolerance to aminoglycosides, macrolide antibiotics, or colony stimulating factors - Requires intravenous fluids
Total Enrollment: 2
Location and Contact Information:
Overall Study Official:
ArthurWhite, Principal Investigator, Baylor College of Medicine
Additional Information:
Study ID Numbers: 2R01AI41735-04A2; 5R01AI041735-05
Study Start Date: September 1997
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057486
Other Cryptosporidiosis Studies:
1. A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
2. A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
3. A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)
4. The Safety and Effectiveness of 524W91
5. Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
Related Studies:
Other Cryptosporidiosis Clinical Trials
Other Clinical Trials
Other Clinical Trials
Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
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