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Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients Clinical research trials and Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients. Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients clinical trial. Participants oftentimes recieve the finest healthcare available for their Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients



Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

For Condition: Cryptosporidiosis,HIV Infections
Status: Terminated
Sponsor(s): Romark Laboratories L.C. ,
Synopsis: The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
Details: Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.
Eligibility:
Study Type:  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have a CD4 cell count of 50 cells/mm3 or less. - Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry. - Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment. - Are able to take medications by mouth. - Are at least 13 years old (consent of parent or guardian required if under 18). - Agree to use an effective method of birth control (such as condoms) during the study. Exclusion Criteria Patients will not be eligible if they: - Have certain diseases or infections of the intestines. - Have ever taken nitazoxanide. - Have taken certain experimental drugs within 14 days of enrollment. - Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin. - Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study. - Are pregnant or breast-feeding.
Total Enrollment: 30

Location and Contact Information:

Julie Ryner
Tampa,  Florida,  33607
United States
 


Additional Information:
Study ID Numbers:  253C;  RM-NTZ-99-003
Study Start Date: February 2000
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004986

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3. A Phase I Study of Autologous, Activated CD8(+) Lymphocytes Expanded In Vitro and Infused With or Without Recombinant Interleukin-2 to Patients With AIDS or Severe ARC

4. Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women

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