Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients

• Status: Terminated
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

There is no proven effective treatment for chronic diarrhea caused by the parasite Cryptosporidium in advanced AIDS. This trial will test the safety of interleukin-12 (IL-12) as part of a combination therapy for this parasite.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interleukin-12

Criteria

Inclusion criteria:

• HIV infection

• CD4 cell count < 150 cells/µl

• Stable antiretroviral regime that includes at least two nucleotide analogues for at least 4 weeks

• Viral load < 10,000 copies/ml

• Chronic diarrhea, defined as three loose or watery bowel movements a day for 5 days per week over 3 weeks

• Stool positive for Cryptosporidium and no other enteric pathogen (bacterial culture, C. difficile toxin assay, AFB stain, ova and parasite examination, and stain for microsporidia)

• Karnofsky score >= 70

• Acceptable methods of contraception

Exclusion Criteria:

• Pregnant

• Active opportunistic infection

• History of hypersensitivity or significant intolerance to aminoglycosides, macrolide antibiotics, or colony stimulating factors

• Requires intravenous fluids