Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients (NCT00057486) | Clinical Trial Compass
TerminatedPhase 1/2
Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
2 participantsStarted 1997-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
Trial details
NCT IDNCT00057486
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)