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A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea Clinical research trials and A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea. A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea clinical trial. Human subjects often obtain the finest healthcare possible for their A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea  A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
For Condition: HIV Infections
Status: Completed
Sponsor(s): Unimed Pharmaceuticals ,
Synopsis: To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients. Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
Details: Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection. Patients are enrolled in groups of 7. Group A receives the lowest dose of NTZ. Groups B - D receive sequentially higher doses. Patients in Groups B - D do not begin therapy until all patients have been enrolled at the preceding dose. For determination of single-dose pharmacokinetics, patients receive a single dose of NTZ on Day 1 and blood samples are obtained over the next 24 hours. Immediately following the 24-hour blood sample collection, patients begin the treatment phase during which they take NTZ for an additional 13 days. Blood samples are obtained again on Day 14 to determine full plasma concentration-time profiles over the dosing interval. At the end of treatment, responders discontinue treatment and nonresponders continue NTZ treatment for an additional 14 days on the same dose. Patients who still fail to respond are provided with an additional month of NTZ. Patients have scheduled visits for clinical and parasitologic efficacy assessments and safety laboratory tests.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - AIDS diagnosis according to CDC criteria. - CD4 count less than or equal to 200 cells/mm3 or CD4 count greater than or equal to 200 cells/mm3 and documented cryptosporidiosis for a minimum of 4 weeks. - Cryptosporidial diarrhea as defined by: - (1) presence of Cryptosporidium oocytes in a stool specimen within 14 days of enrollment; and (2) chronic diarrhea (i.e., an average of at least 4 bowel movements per day for a minimum of 2 weeks). - Life expectancy of at least 1 month. - Ability to tolerate food by mouth. Prior Medication: Required: - Any anti-diarrheal or anti-emetic medication for which the dosage regimen has been stable for at least 1 week prior to enrollment. - Any antiretroviral medications (e.g., zidovudine, ddI, ddC) for which the dosage regimen has been stable for at least 3 weeks prior to enrollment. Allowed: Medication for prophylaxis or maintenance therapy of opportunistic infection, stable for at least 2 weeks prior to enrollment. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.) Patients with the following prior conditions are excluded: - Presence of Salmonella, Shigella, Campylobacter, Yersinia, Giardia lamblia, Entamoeba histolytica, Microsporidia, Isospora, Cyclospora, or Clostridium difficile toxin in stool (based on assessment within 14 days prior to enrollment by stool ova and parasite examination, culture, and C. difficile assay). - History of intestinal Mycobacterium avium intracellular infection or intestinal Kaposi's sarcoma. - History of Cytomegalovirus colitis, unless 28 days of therapy with ganciclovir or foscarnet completed subsequent to diagnosis. Prior Medication: Excluded: - Investigational drug therapy within 14 days of enrollment, unless available under an FDA-authorized expanded access program. - Any drug or therapy with possible anticryptosporidial activity (e.g., paromomycin, spiramycin, azithromycin, clarithromycin, hyperimmune bovine colostrum) within 14 days of enrollment.
Total Enrollment: 28
Location and Contact Information:
Overall Study Official:
RosemarySoave, Principal Investigator,
New York Hosp / Cornell Med Ctr
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: 253A; UMD-95-004
Study Start Date: October 1995
Record last reviewed: February 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002444
Other Hiv Infections Studies:
1. The Safety and Effectiveness of 935U83 in HIV-Infected Patients
2. A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy
3. Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients with the Acquired Immunodeficiency Syndrome
4. Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
5. Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma
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A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
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