PRIMARY: To assess the effect of bovine anti-Cryptosporidium immunoglobulin (BACI) on the volume of diarrhea due to Cryptosporidium parvum in AIDS patients who have protracted Cryptosporidium enteritis. SECONDARY: To assess changes in stool consistency and frequency, body weight, and safety in this patient population.

Condition	Treatment or Intervention	Phase
Cryptosporidiosis HIV Infections	Drug: Cryptosporidium Immune Whey Protein Concentrate (Bovine)	Phase I

Further Study Details: 

Expected Total Enrollment:  40

Forty patients are randomized to receive either BACI or placebo (bovine colostrum from non-immunized cattle) for 1 week. The double-blind portion of the study will be followed by an open-label phase in which all 40 patients receive BACI for 1 week.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Antidiarrheal compounds (if dose remains stable).
• Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose was stable for at least 4 weeks prior to study entry). Patients must have:
• AIDS.
• Cryptosporidium parvum enteritis.
• Chronic diarrhea.
• Life expectancy of at least 4 weeks.
• Ability to tolerate food by mouth.
• Ability to take the histamine H2-receptor antagonist famotidine (Pepcid). Prior Medication: Allowed:
• Antidiarrheal compounds (provided dose has remained stable in the 7 days prior to study entry).
• Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), or alternative HIV therapy (provided dose has remained stable for at least 4 weeks prior to study entry).

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Concurrent unresolved clinical infections with enteric pathogens other than C. parvum (e.g., rotavirus, Salmonella, Shigella, Campylobacter, Giardia, C. difficile toxin, Yersinia, amebiasis, MAI, CMV, Microsporida) as determined by history or routine microbiology screening.
• Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis.
• Grossly bloody diarrhea.
• Known allergy to milk or milk products (other than lactose intolerance). Prior Medication: Excluded:
• Other experimental therapy (e.g., macrolide antibiotics, paromomycin) within 30 days prior to study entry.

California
      UCSF - San Francisco Gen Hosp, San Francisco,  California,  94110,  United States
      Gabin Med Group, Los Angeles,  California,  90067,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Massachusetts
      Saint Elizabeth's Hosp, Boston,  Massachusetts,  02135,  United States
      New England Med Ctr, Boston,  Massachusetts,  02111,  United States
New York
      Cornell Univ Med Ctr, New York,  New York,  10021,  United States

Study ID Numbers:  081A; UNX-4101
Record last reviewed:  April 1993
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002248
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08