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| Sponsor: | Univax Biologics Inc |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002248 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cryptosporidiosis HIV Infections |
Drug: Cryptosporidium Immune Whey Protein Concentrate (Bovine) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Prior Medication:
Excluded:
Contacts and Locations| United States, California | |
| Gabin Med Group | |
| Los Angeles, California, United States, 90067 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Massachusetts | |
| Saint Elizabeth's Hosp | |
| Boston, Massachusetts, United States, 02135 | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| United States, New York | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002248 History of Changes |
| Other Study ID Numbers: | 081A, UNX-4101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Antidiarrheals Cryptosporidiosis Diarrhea |
Acquired Immunodeficiency Syndrome Cryptosporidium Immunization, Passive |
|
HIV Infections Acquired Immunodeficiency Syndrome Cryptosporidiosis Enteritis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Intestinal Diseases, Parasitic |
Parasitic Diseases Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiosis Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Immunoglobulins Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |