|
A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 Clinical research trials and A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3. A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 clinical trial. Subjects frequently get the best healthcare possible for their A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3  A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3
A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3
For Condition: Cryptosporidiosis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit. In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
Details: In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy. Patients are randomized to receive either placebo or paromomycin for 3 weeks. After the initial double-blind phase, all patients receive open-label paromomycin for 3 weeks. Following 6 weeks of therapy, patients who do not achieve a complete response receive a higher dose of paromomycin for an additional 3 weeks, while complete responders continue receiving the original dose for an additional 3 weeks. Complete or partial responders after 9 weeks may receive 16 additional weeks of optional maintenance therapy at the dose at which their response was achieved. Treatment continues for up to 25 weeks total. Patients are followed at weeks 1, 3, 4, 6, 7, and 9, and then at 2-4 week intervals.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral therapy. - Macrolides for disseminated Mycobacterium avium. - Atovaquone for toxoplasmosis. - Other antimicrobials for concurrent infections. - Lomotil, Imodium, or deodorized opium tincture in a standardized regimen for diarrhea. Patients must have: - Advanced HIV disease. - Diarrhea presumptively caused by Cryptosporidia. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Hypersensitivity to aminoglycosides. - Inability to swallow capsules. - Active infection due to other enteric pathogens. Previous diagnosis of CMV or MAC infection permitted if patient is currently stabilized on a therapeutic regimen (clarithromycin up to 500 mg bid or azithromycin up to 600 mg daily). - Other known causes for diarrhea (e.g., malabsorption syndrome, gastrointestinal Kaposi's sarcoma). Concurrent Medication: Excluded during the first 9 weeks of study: - Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum). - Octreotide acetate (Sandostatin). - Antidiarrheals other than those specifically allowed. - Clarithromycin if initiated at 500 mg or higher or azithromycin if initiated at 600 mg or higher. Prior Medication: Excluded: - Paromomycin at > 1 g/day for >= 14 days prior to study entry. Excluded within 14 days prior to study entry: - Agents with putative anticryptosporidial activity (such as spiramycin, diclazuril, letrazuril, or bovine colostrum), with the exception of macrolides that are permitted for other indications. - Octreotide acetate (Sandostatin).
Total Enrollment: 68
Location and Contact Information:
Overall Study Official:
CareyJ, Study Chair,
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Additional Information:
Study ID Numbers: ACTG 192;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000771
Other Hiv Infections Studies:
1. HIV Infection in Homosexual and Bisexual Men
2. An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium avium-intracellulare Complex Infection (MAC) in Patients with Acquired Immune Deficiency Syndrome (AIDS)
3. SU5416 in Patients with AIDS-Related Kaposi's Sarcoma
4. Use of a Test that Evaluates How the Body Handles Insulin and Glucose
5. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3
|
|
|
|
|
|
|
|
