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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: | NCT00000771 |
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.
Condition | Intervention | Phase |
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Cryptosporidiosis HIV Infections |
Drug: Paromomycin sulfate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 68 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded during the first 9 weeks of study:
Prior Medication:
Excluded:
Excluded within 14 days prior to study entry:
United States, California | |
Stanford at Kaiser / Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
Louis A Weiss Memorial Hosp | |
Chicago, Illinois, United States, 60640 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
Methodist Hosp of Indiana / Life Care Clinic | |
Indianapolis, Indiana, United States, 46202 | |
United States, New York | |
SUNY / State Univ of New York | |
Syracuse, New York, United States, 13210 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Jack Weiler Hosp / Bronx Municipal Hosp | |
Bronx, New York, United States, 10465 | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
Bronx, New York, United States, 10461 | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
Columbia Presbyterian Med Ctr | |
New York, New York, United States, 100323784 | |
Montefiore Med Ctr Adolescent AIDS Program | |
Bronx, New York, United States, 10467 | |
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp | |
Bronx, New York, United States, 10461 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
Puerto Rico | |
Univ of Puerto Rico | |
San Juan, Puerto Rico, 009365067 |
Study Chair: | Carey J |
Study ID Numbers: | ACTG 192 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000771 |
Health Authority: | United States: Federal Government |
Cryptosporidiosis Acquired Immunodeficiency Syndrome Paromomycin |
Protozoan Infections Sexually Transmitted Diseases, Viral Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Intestinal Diseases Paromomycin Immunologic Deficiency Syndromes Virus Diseases |
Cryptosporidiosis Digestive System Diseases HIV Infections Sexually Transmitted Diseases Parasitic Diseases Intestinal Diseases, Parasitic Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Immune System Diseases Coccidiosis Infection Pharmacologic Actions |
Anti-Bacterial Agents Antiparasitic Agents Therapeutic Uses Lentivirus Infections Protozoan Infections, Animal Parasitic Diseases, Animal Amebicides |