A Phase 1 interventional study of Cryptosporidium Immune Whey Protein Concentrate (Bovine) in Cryptosporidiosis and HIV Infections, sponsored by Univax Biologics Inc. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Univax Biologics Inc · Phase 1, Interventional, and Treatment
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Among 17 studies in Cryptosporidiosis with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Cryptosporidiosis · United States.
Among the 17 studies in Cryptosporidiosis with a site in United States, this one is the 5th largest by enrollment of the 10 interventional ones that give a count, is one of 4 in phase 1, and was the 1st registered.
32 studies on the registry are indexed under Cryptosporidiosis; 6 are open to participants now.
Browse Cryptosporidiosis studies →1 of the 17 studies in Cryptosporidiosis with a site in United States is open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States
Ages 18–50 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Cryptosporidiosis studies recruiting now, 1 sets no upper age limit and 3 stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 1977; this study’s year is marked.
This study's enrollment of 40 is close to the median of 40 across 17 interventional studies indexed under Cryptosporidiosis.
Median enrollment 36 across the 10 interventional studies, 150 across the 1 observational. Of the 15 that completed or were terminated, 1 (7%) have results posted.
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12 of 17 have an industry lead sponsor. The 8 most frequent:
This is the only study on the registry with Univax Biologics Inc as lead sponsor.
Univax Biologics Inc has 1 study filed under Cryptosporidiosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Cryptosporidiosis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07249463Novartis PharmaceuticalsStudy Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults | 2027-03-23 |
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Among the 17 studies in Cryptosporidiosis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is completed, as verified in Apr 1993. You cannot join it, but the record below documents what was studied.
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