Clinical trial NCT00002248: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients
Official title: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cryptosporidiosis
HIV Infections
Keywords: Antidiarrheals
Cryptosporidiosis
Diarrhea
Acquired Immunodeficiency Syndrome
Cryptosporidium
Immunization, Passive
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Gabin Med Group
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: Boston
country: United States
facility: Saint Elizabeth's Hosp
state: Massachusetts
city: New York
country: United States
facility: Cornell Univ Med Ctr
state: New York
Study officials:
References:
citation: Nord J, Ma P, Tacket CO, Dijohn D, Tzipori S, Sahner D, Shieb G. Treatment of AIDS associated cryptosporidiosis with hyperimmune colostrum from cows vaccinated with cryptosporidium. Int Conf AIDS. 1989 Jun 4-9;5:656 (abstract no C586)