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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: | Treatment, Double-Blind, Safety Study |
| 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 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| Gabin Med Group | |
| Los Angeles, California, United States, 90067 | |
| 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
| Study ID Numbers: | 081A, UNX-4101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002248 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antidiarrheals Cryptosporidiosis Diarrhea |
Acquired Immunodeficiency Syndrome Cryptosporidium Immunization, Passive |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Gastrointestinal Diseases Physiological Effects of Drugs Infection Cryptosporidiosis Parasitic Diseases Parasitic Diseases, Animal Retroviridae Infections Immunoglobulins Protozoan Infections RNA Virus Infections Immune System Diseases |
Coccidiosis Enteritis Acquired Immunodeficiency Syndrome Intestinal Diseases Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Protozoan Infections, Animal Intestinal Diseases, Parasitic Gastroenteritis |