Overview

Treatment of Chronic Cryptosporidiosis in AIDS Patients

Status:
Terminated
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Genetics Institute
Treatments:
Azithromycin
Interleukin-12
Paromomycin
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.