Status:
TERMINATED
Treatment of Chronic Cryptosporidiosis in AIDS Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Genetics Institute
Conditions:
Cryptosporidiosis
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS p...
Detailed Description
Cryptosporidium parvum, an intracellular protozoan parasite, is a frequent cause of chronic diarrhea in HIV-infected patients, causing significant morbidity and mortality. Highly effective antiparasit...
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a CD4 cell count below 150 cells/mm3.
- Have been on stable anti-HIV therapy that includes at least 2 nucleoside analogues for at least 4 weeks.
- Have chronic diarrhea (3 bowel movements a day that are loose or watery, for 5 days per week over 3 weeks).
- Test positively for Cryptosporidium.
- Are at least 18 years old.
- Agree to use effective methods of birth control.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have any other active opportunistic (AIDS-related) infection.
- Require intravenous (IV) fluids.
- Have a history of an allergy to certain medications, such as colony-stimulating factors (G-CSF or GM-CSF) or a type of antibiotic.
- Are pregnant.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00001128
End Date
June 1 2005
Last Update
December 14 2016
Active Locations (1)
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1
Pablo C. Okhuysen
Houston, Texas, United States, 77030