Treatment of Chronic Cryptosporidiosis in AIDS Patients
Stopped early · Not applicable
Conditions studied: Cryptosporidiosis, HIV Infections
In brief
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 patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone. Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.
Key facts
- Study ID
- NCT00001128
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 16
- Expected to finish
- 2005-06-01
- Last updated by the study team
- 2016-12-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pablo C. Okhuysen — Houston, Texas, United States
Full record on ClinicalTrials.gov
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