HIV-associated Enteropathy Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Study Evaluating the Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in HIV+ Subjects With HIV-associated Enteropathy.
| Verified date | February 2016 |
| Source | Entera Health, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | September 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - History of HIV-1 infection - Plasma HIV viral load =40 copies/mL - Maintained virologic suppression for 1 year - Stable Antiretroviral Therapy (ART) regimen - History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed stools per day or a liquid stool volume greater than 200 g per day for at least 4 weeks duration Exclusion Criteria: - Positive stool test for pathogenic bacteria, C. difficile or ova and parasites - Conditions that require chronic therapy that is known to alter gut microbiota - Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Therafirst | Fort Lauderdale | Florida |
| United States | AIDS Research Alliance | Los Angeles | California |
| United States | Univ of California Davis CARES Clinic | Sacramento | California |
| United States | Univ of California SF | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Entera Health, Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418) | 4 weeks | No | |
| Other | Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418) | 6 months | No | |
| Other | Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities in Biopsy Subjects | 6 months | No | |
| Primary | Frequency of Daily Unformed Bowel Movements | Change in number of abnormal or unformed stools by week 4 | 4 weeks | No |