Completed

Bovine Anti-Cryptosporidium Immunoglobulin (BACI) for Cryptosporidium Enteritis in AIDS Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Cryptosporidium Immune Whey Protein Concentrate (Bovine)

Drug
Who is being recruted

Blood-Borne Infections+28

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorUnivax Biologics Inc
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002248
Principal SponsorUnivax Biologics Inc
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAnimal DiseasesCoccidiosisCommunicable DiseasesDigestive System DiseasesGastrointestinal DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsIntestinal DiseasesIntestinal Diseases, ParasiticParasitic DiseasesParasitic Diseases, AnimalProtozoan InfectionsProtozoan Infections, AnimalRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsSigns and Symptoms, DigestiveSlow Virus DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCryptosporidiosisDiarrheaHIV Infections

Criteria

10 inclusion criteria required to participate
Life expectancy of at least 4 weeks.
Ability to tolerate food by mouth.
Ability to take the histamine H2-receptor antagonist famotidine (Pepcid).
Cryptosporidium parvum enteritis.
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5 exclusion criteria prevent from participating
Other acute infections or concurrent immediately life-threatening medical crisis other than cryptosporidiosis.
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.
Known allergy to milk or milk products (other than lactose intolerance).
Grossly bloody diarrhea.
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Gabin Med Group

Los Angeles, United StatesOpen Gabin Med Group in Google Maps

UCSF - San Francisco Gen Hosp

San Francisco, United States

AIDS Research Consortium of Atlanta

Atlanta, United States

New England Med Ctr

Boston, United States
Completed6 Study Centers