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
- CryptosporidiosisHIV Infections
- Registration Number
- NCT00000771
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (15)
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
USC CRS
🇺🇸Los Angeles, California, United States
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Weiss Memorial Hosp.
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Cornell University A2201
🇺🇸New York, New York, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States